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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01751906
Registration number
NCT01751906
Ethics application status
Date submitted
13/12/2012
Date registered
18/12/2012
Date last updated
11/10/2023
Titles & IDs
Public title
ABSORB III Randomized Controlled Trial (RCT)
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Scientific title
A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions.
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Secondary ID [1]
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10-392
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Universal Trial Number (UTN)
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Trial acronym
ABSORB-III
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease
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Coronary Artery Stenosis
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0
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Coronary Disease
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0
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Coronary Stenosis
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0
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Condition category
Condition code
Cardiovascular
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0
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Coronary heart disease
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Cardiovascular
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0
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0
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Other cardiovascular diseases
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Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Absorb BVS
Treatment: Devices - XIENCE
Experimental: Absorb BVS - Subjects receiving Absorb BVS
Active Comparator: XIENCE - Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
Treatment: Devices: Absorb BVS
Scaffold diameters: 2.5, 3.0 and 3.5 mm
Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length = 24 mm) with a reference vessel diameter of = 2.5 mm and = 3.75 mm.
Treatment: Devices: XIENCE
Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length = 24 mm) with a reference vessel diameter of = 2.5 mm and = 3.75 mm.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Cardiac Death/TV-MI/ID-TLR (TLF)
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Assessment method [1]
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TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
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Timepoint [1]
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1 year
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Secondary outcome [1]
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Number of Participants With Powered Secondary Endpoint: Angina
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Assessment method [1]
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Angina is defined as the first adverse event resulting in the site diagnosis of angina.
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Timepoint [1]
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1 year
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Secondary outcome [2]
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Number of Participants With Powered Secondary Endpoint: All Revascularization
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Assessment method [2]
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This powered secondary endpoint is intended to assess all revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. All revascularizations are comprised of TLR, TVR excluding TLR, and non-TVR.
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Timepoint [2]
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1 year
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Secondary outcome [3]
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Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR)
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Assessment method [3]
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This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE.
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Timepoint [3]
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1 year
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Secondary outcome [4]
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Acute Success- Device Success (Lesion Level Analysis)
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Assessment method [4]
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Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.
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Timepoint [4]
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On day 0 (the day of procedure)
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Secondary outcome [5]
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Acute Success: Procedural Success (Subject Level Analysis)
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Assessment method [5]
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Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).
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Timepoint [5]
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On day 0 (the day of procedure)
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Secondary outcome [6]
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Number of Death (Cardiac, Vascular, Non-cardiovascular)
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Assessment method [6]
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DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
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Timepoint [6]
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0 to 5 years
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Secondary outcome [7]
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Number of Participants With All Myocardial Infarction (MI)
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Assessment method [7]
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Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)
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Timepoint [7]
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0 to 5 years
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Secondary outcome [8]
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Number of Participants With All Target Lesion Revascularization (TLR)
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Assessment method [8]
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TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.
The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
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Timepoint [8]
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0 to 5 years
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Secondary outcome [9]
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Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)
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Assessment method [9]
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TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
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Timepoint [9]
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0 to 5 years
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Secondary outcome [10]
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Number of Participants With All Revascularization
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Assessment method [10]
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All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.
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Timepoint [10]
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0 to 5 years
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Secondary outcome [11]
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Number of Death/All MI
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Assessment method [11]
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All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
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Timepoint [11]
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0 to 5 years
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Secondary outcome [12]
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Number of Cardiac Death/All MI
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Assessment method [12]
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All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Those MIs which are not Q-wave MI
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Timepoint [12]
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0 to 5 years
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Secondary outcome [13]
0
0
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
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Assessment method [13]
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Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
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Timepoint [13]
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0 to 5 years
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Secondary outcome [14]
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0
Number of Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
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Assessment method [14]
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Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
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Timepoint [14]
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0 to 5 years
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Secondary outcome [15]
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0
Number of Participants With Target Vessel Failure (TVF)
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Assessment method [15]
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0
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
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Timepoint [15]
0
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0 to 5 years
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Secondary outcome [16]
0
0
Number of Death/All MI/All Revascularization (DMR)
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Assessment method [16]
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DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
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Timepoint [16]
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0 to 5 years
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Secondary outcome [17]
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0
Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition)
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Assessment method [17]
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Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing :
Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.
Evidence:
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.
Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
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Timepoint [17]
0
0
= 1 Day
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Secondary outcome [18]
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0
Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition)
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Assessment method [18]
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0
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing :
Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.
Evidence:
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.
Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
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Timepoint [18]
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0
0 to 30 Days
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Secondary outcome [19]
0
0
Number of Participants With Subacute Stent/Scaffold Thrombosis
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Assessment method [19]
0
0
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing :
Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.
Evidence:
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.
Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
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Timepoint [19]
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0
>1 to 30 Days
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Secondary outcome [20]
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Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)
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Assessment method [20]
0
0
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing :
Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.
Evidence:
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.
Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of
Any unexplained death within the first 30 days or
Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
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Timepoint [20]
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31 to 365 Days
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Secondary outcome [21]
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0
Number of Participants With Very Late Stent /Scaffold Thrombosis (Per ARC Definition)
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Assessment method [21]
0
0
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing :
Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.
Evidence:
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.
Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of
Any unexplained death within the first 30 days or
Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
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Timepoint [21]
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366 to 393 Days
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Secondary outcome [22]
0
0
Number of Participants With Cumulative Stent/Scaffold Thrombosis
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Assessment method [22]
0
0
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing :
Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.
Evidence:
Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.
Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of
Any unexplained death within the first 30 days or
Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
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Timepoint [22]
0
0
0 to 1853 Days
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Secondary outcome [23]
0
0
Pre-Procedure Minimum Lumen Diameter (MLD)
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Assessment method [23]
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0
Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.
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Timepoint [23]
0
0
< or = 1 day
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Secondary outcome [24]
0
0
Pre-Procedure Percent Diameter Stenosis (%DS)
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Assessment method [24]
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Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
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Timepoint [24]
0
0
< or = 1 day
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Secondary outcome [25]
0
0
Post-Procedure In-Segment Minimum Lumen Diameter (MLD)
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Assessment method [25]
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Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.
In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
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Timepoint [25]
0
0
= 7 days post index procedure
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Secondary outcome [26]
0
0
Post-Procedure In-Segment Percent Diameter Stenosis (%DS)
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Assessment method [26]
0
0
Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
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Timepoint [26]
0
0
= 7 days post index procedure
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Secondary outcome [27]
0
0
Post-Procedure In-Device Minimum Lumen Diameter (MLD)
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Assessment method [27]
0
0
Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.
In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold
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Timepoint [27]
0
0
= 7 days post index procedure
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Secondary outcome [28]
0
0
Post-Procedure In-Device Percent Diameter Stenosis (%DS)
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Assessment method [28]
0
0
Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
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Timepoint [28]
0
0
= 7 days post index procedure
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Secondary outcome [29]
0
0
Post-Procedure In-Device Acute Gain
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Assessment method [29]
0
0
The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
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Timepoint [29]
0
0
= 7 days post index procedure
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Secondary outcome [30]
0
0
Powered Imaging Cohort Secondary Endpoint: The Instent/Scaffold Mean Lumen Area Change, From Post Procedure to 3 Years by Intravascular Ultrasound (IVUS)
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Assessment method [30]
0
0
Mean lumen area measured after nitrate infusions, superiority test, ~300 pooled subjects.
Pooled IVUS subjects (~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT.
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Timepoint [30]
0
0
From Post procedure to 3 Years
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Secondary outcome [31]
0
0
Optical Coherence Tomography (OCT) Endpoint: Mean Neointimal Area (NIA)
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Assessment method [31]
0
0
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
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Timepoint [31]
0
0
3 Years
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Secondary outcome [32]
0
0
Optical Coherence Tomography (OCT) Endpoint: Mean Device Area, Adluminal
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Assessment method [32]
0
0
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
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Timepoint [32]
0
0
3 Years
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Secondary outcome [33]
0
0
Optical Coherence Tomography (OCT) Endpoint: Mean Lumen Area
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Assessment method [33]
0
0
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
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Timepoint [33]
0
0
3 Years
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Secondary outcome [34]
0
0
Optical Coherence Tomography (OCT) Endpoint: Minimal Lumen Area
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Assessment method [34]
0
0
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
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Timepoint [34]
0
0
3 Years
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Secondary outcome [35]
0
0
Optical Coherence Tomography (OCT) Endpoint: Percentage of Malapposition Struts
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Assessment method [35]
0
0
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
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Timepoint [35]
0
0
3 Years
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Eligibility
Key inclusion criteria
General
1. Subject must be at least 18 years of age.
2. Subject or a legally authorized representative must provide written Informed Consent
prior to any study related procedure, per site requirements.
3. Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina,
post-infarct angina or silent ischemia) suitable for elective PCI. Subjects with
stable angina or silent ischemia and < 70% diameter stenosis must have objectives sign
of ischemia as determined by one of the following, echocardiogram, nuclear scan,
ambulatory ECG or stress ECG). In the absence of noninvasive ischemia, fractional flow
reserve (FFR) must be done and indicative of ischemia.
4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG)
surgery.
5. Female subject of childbearing potential who does not plan pregnancy for up to 1 year
following the index procedure. For a female subject of childbearing potential a
pregnancy test must be performed with negative results known within 7 days prior to
the index procedure per site standard.
6. Female subject is not breast-feeding at the time of the screening visit and will not
be breast-feeding for up to 1 year following the index procedure.
7. Subject agrees to not participate in any other investigational or invasive clinical
study for a period of 1 year following the index procedure.
Angiographic
1. One or two de novo target lesions:
1. If there is one target lesion, a second non-target lesion may be treated but the
non-target lesion must be present in a different epicardial vessel, and must be
treated first with a successful, uncomplicated result prior to randomization of
the target lesion.
2. If two target lesions are present, they must be present in different epicardial
vessels and both must satisfy the angiographic eligibility criteria.
3. The definition of epicardial vessels means the LAD, LCX and RCA and their
branches. Thus, the patient must not have lesions requiring treatment in e.g.
both the LAD and a diagonal branch.
2. Target lesion(s) must be located in a native coronary artery with a visually estimated
or quantitatively assessed %DS of = 50% and < 100% with a TIMI flow of = 1 and one of
the following: stenosis = 70%, an abnormal functional test (e.g., fractional flow
reserve, stress test), unstable angina or post-infarct angina.
1. Lesion(s) must be located in a native coronary artery with RVD by visual
estimation of = 2.50 mm and = 3.75 mm.
2. Lesion(s) must be located in a native coronary artery with length by visual
estimation of = 24 mm.
3. For Lead-In subjects with 3.0x18 mm Absorb BVS: lesions (s) must be located in a
native coronary artery with RVD by visual estimation of = 2.75 mm and = 3.25 mm.
The lesion length by visual estimation is = 8 mm and = 14 mm.
General
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP
antagonist is planned within 12 months after the procedure.
2. Subject has known hypersensitivity or contraindication to device material and its
degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and
cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot
be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be
adequately pre-medicated.
3. Subject has known allergic reaction, hypersensitivity or contraindication to aspirin;
or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and
therefore cannot be adequately treated with study medications.
4. Subject had an acute myocardial infarction (AMI; STEMI or NSTEMI) within 72 hours of
the index procedure and both CK and CK-MB have not returned to within normal limits at
the time of index procedure; or subject with stable angina or silent ischemia has
CK-MB that is greater than normal limits at the time of the index procedure.
5. Subject is currently experiencing clinical symptoms consistent with new onset AMI
(STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG
changes.
6. Subject has a cardiac arrhythmia as identified at the time of screening for which at
least one of the following criteria is met:
1. Subject requires coumadin or any other agent for chronic oral anticoagulation.
2. Subject is likely to become hemodynamically unstable due to their arrhythmia.
3. Subject has poor survival prognosis due to their arrhythmia.
7. Subject has a left ventricular ejection fraction (LVEF) < 30% assessed by any
quantitative method, including but not limited to echocardiography, MRI,
Multiple-Gated Acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc.
LVEF may be obtained within 6 months prior to the procedure for subjects with stable
CAD. For subjects presenting with ACS, LVEF must be assessed during the index
hospitalization (which may include during the index procedure by contrast left
ventriculography) but prior to randomization in order to confirm the subject's
eligibility.
8. Subject has undergone prior PCI within the target vessel during the last 12 months.
Prior PCI within the non-target vessel or any peripheral intervention is acceptable if
performed anytime >30 days before the index procedure, or between 24 hours and 30 days
before the index procedure if successful and uncomplicated.
9. Subject requires future staged PCI either in target or non-target vessels or subject
requires future peripheral interventions < 30 days after the index procedure
10. Subject has received any solid organ transplants or is on a waiting list for any solid
organ transplants.
11. At the time of screening, the subject has a malignancy that is not in remission.
12. Subject is receiving immunosuppressant therapy or has known immunosuppressive or
severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human
immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are
not included as immunosuppressant therapy.
13. Subject has previously received or is scheduled to receive radiotherapy to a coronary
artery (vascular brachytherapy), or the chest/mediastinum.
14. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin,
dabigatran, apixaban, rivaroxaban or any other agent for any reason).
15. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
16. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or
Child-Pugh = Class B.
17. Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min/1.73m2 or
dialysis at the time of screening.
18. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis
or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed
within the past six months.
19. Subject has had a cerebrovascular accident or transient ischemic neurological attack
(TIA) within the past six months, or any prior intracranial bleed, or any permanent
neurologic defect, or any known intracranial pathology (e.g. aneurysm, arteriovenous
malformation, etc.).
20. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath
insertion. Note: femoral arterial disease does not exclude the patient if radial
access may be used.
21. Subject has life expectancy < 5 years for any non-cardiac cause or cardiac cause.
22. Subject is in the opinion of the Investigator or designee, unable to comply with the
requirements of the study protocol or is unsuitable for the study for any reason. This
includes completion of Patient Reported Outcome instruments.
23. Subject is currently participating in another clinical trial that has not yet
completed its primary endpoint.
24. Subject is part of a vulnerable population who, in the judgment of the investigator,
is unable to give Informed Consent for reasons of incapacity, immaturity, adverse
personal circumstances or lack of autonomy. This may include: Individuals with mental
disability, persons in nursing homes, children, impoverished persons, persons in
emergency situations, homeless persons, nomads, refugees, and those incapable of
giving informed consent. Vulnerable populations also may include members of a group
with a hierarchical structure such as university students, subordinate hospital and
laboratory personnel, employees of the Sponsor, members of the armed forces, and
persons kept in detention.
Angiographic
All exclusion criteria apply to the target lesion(s) or target vessel(s).
1. Lesion which prevents successful balloon pre-dilatation, defined as full balloon
expansion with the following outcomes:
1. Residual %DS is a maximum < 40% (per visual estimation), = 20% is strongly
recommended.
2. TIMI Grade-3 flow (per visual estimation).
3. No angiographic complications (e.g. distal embolization, side branch closure).
4. No dissections NHLBI grade D-F.
5. No chest pain lasting > 5 minutes.
6. No ST depression or elevation lasting > 5 minutes.
2. Lesion is located in left main.
3. Aorto-ostial RCA lesion (within 3 mm of the ostium).
4. Lesion located within 3 mm of the origin of the LAD or LCX.
5. Lesion involving a bifurcation with a:
1. side branch = 2 mm in diameter, or
2. side branch with either an ostial or non-ostial lesion with diameter stenosis >
50%, or
3. side branch requiring dilatation
6. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or
XIENCE stent:
1. Extreme angulation (= 90°) proximal to or within the target lesion.
2. Excessive tortuosity (= two 45° angles) proximal to or within the target lesion.
3. Moderate or heavy calcification proximal to or within the target lesion. If IVUS
used, subject must be excluded if calcium arc in the vessel prior to the lesion
or within the lesion is = 180°.
7. Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.
8. Lesion or vessel involves a myocardial bridge.
9. Vessel has been previously treated with a stent at any time prior to the index
procedure such that the Absorb BVS or XIENCE would need to cross the stent to reach
the target lesion.
10. Vessel has been previously treated and the target lesion is within 5 mm proximal or
distal to a previously treated lesion.
11. Target lesion located within an arterial or saphenous vein graft or distal to any
arterial or saphenous vein graft.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2020
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Sample size
Target
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Accrual to date
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Final
2008
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital - Herston
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St. Vincent's Hospital Melbourne - Fitzroy
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4029 - Herston
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3065 - Fitzroy
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Recruitment outside Australia
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Alabama
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Vermont
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Wisconsin
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott Medical Devices
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Address
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Ethics approval
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Summary
Brief summary
The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the
pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular
Scaffold (BVS).
The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study
and ABSORB IV RCT trial which are maintained under one protocol because both trial designs
are related, ABSORB IV is the continuation of ABSORB III and the data from ABSORB III and
ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will
evaluate the safety and effectiveness of Absorb BVS.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01751906
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Stephen G Ellis, MD
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Cleveland Clinic, Cleveland OH
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01751906
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