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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/NCT01308346
Registration number
NCT01308346
Ethics application status
Date submitted
2/03/2011
Date registered
4/03/2011
Date last updated
7/05/2013
Titles & IDs
Public title
ABSORB PHYSIOLOGY Clinical Investigation
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Scientific title
ABSORB PHYSIOLOGY Clinical Investigation: Clinical Evaluation of the Short and Long-Term Effects of the Abbott Vascular Everolimus-Eluting Bioresorbable Vascular Scaffold on Coronary Artery Blood Flow and Physiological Responsiveness
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Secondary ID [1]
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10-390
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Universal Trial Number (UTN)
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Trial acronym
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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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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)
Treatment: Devices - XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
Experimental: Bioresorbable Vascular Scaffold (BVS) - Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)
Active Comparator: XIENCE V® or XIENCE PRIME® - XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) or XIENCE PRIME®
Treatment: Devices: Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)
Bioabsorbable Everolimus Eluting Coronary Stent
Treatment: Devices: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
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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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Coronary artery endothelial responsiveness
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Assessment method [1]
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Change of vessel diameter by 1) pacing, 2) hand-grip and 3) acetylcholine injection
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Timepoint [1]
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Post procedure
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Secondary outcome [1]
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Coronary artery cross-sectional compliance and cross-sectional distensibility
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Assessment method [1]
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Cross-sectional compliance is defined as change in area per unit change in pressure; cross-sectional distensibility is defined as compliance/diastolic cross-sectional area.
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Timepoint [1]
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Post procedure
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Secondary outcome [2]
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Target artery endothelial shear stress distribution
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Assessment method [2]
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Wall Shear Stress (WSS) will be determined from flow velocity and blood viscosity
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Timepoint [2]
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Post procedure
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Secondary outcome [3]
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Wave intensity patterns in the coronary arteries
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Assessment method [3]
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Looking at re-distribution of energy in the blood flow along the coronary artery.
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Timepoint [3]
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Post procedure
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Secondary outcome [4]
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Systolic and diastolic coronary artery impedance
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Assessment method [4]
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Timepoint [4]
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Post procedure
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Secondary outcome [5]
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Clinical device success
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Assessment method [5]
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Successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system.
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Timepoint [5]
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Post procedure
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Secondary outcome [6]
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Clinical Procedure Success
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Assessment method [6]
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Successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system without the occurrence of ischemia driven major adverse cardiac event (MACE).
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Timepoint [6]
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during the hospital stay with a maximum of 7 days post index procedure.
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Secondary outcome [7]
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Cardiac Death (CD)
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Assessment method [7]
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Timepoint [7]
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180 days
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Secondary outcome [8]
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Cardiac Death (CD)
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Assessment method [8]
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Timepoint [8]
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1 year
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Secondary outcome [9]
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Cardiac Death (CD)
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Assessment method [9]
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0
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Timepoint [9]
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2 years
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Secondary outcome [10]
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Myocardial Infarction (MI)
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Assessment method [10]
0
0
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Timepoint [10]
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180 days
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Secondary outcome [11]
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Myocardial Infarction (MI)
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Assessment method [11]
0
0
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Timepoint [11]
0
0
1 year
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Secondary outcome [12]
0
0
Myocardial Infarction (MI)
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Assessment method [12]
0
0
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Timepoint [12]
0
0
2 years
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Secondary outcome [13]
0
0
Target Vessel Myocardial Infarction (TV-MI)
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Assessment method [13]
0
0
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Timepoint [13]
0
0
180 days
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Secondary outcome [14]
0
0
Target Vessel Myocardial Infarction (TV-MI)
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Assessment method [14]
0
0
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Timepoint [14]
0
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1 year
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Secondary outcome [15]
0
0
Target Vessel Myocardial Infarction (TV-MI)
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Assessment method [15]
0
0
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Timepoint [15]
0
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2 years
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Secondary outcome [16]
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All Death, All MI, All Revascularization (DMR)
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Assessment method [16]
0
0
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Timepoint [16]
0
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180 days
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Secondary outcome [17]
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0
All Death, All MI, All Revascularization (DMR)
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Assessment method [17]
0
0
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Timepoint [17]
0
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1 year
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Secondary outcome [18]
0
0
All Death, All MI, All Revascularization (DMR)
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Assessment method [18]
0
0
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Timepoint [18]
0
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2 years
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Secondary outcome [19]
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Ischemia-Driven MACE (ID-MACE)
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Assessment method [19]
0
0
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Timepoint [19]
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180 days
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Secondary outcome [20]
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Ischemia-Driven MACE (ID-MACE)
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Assessment method [20]
0
0
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Timepoint [20]
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1 year
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Secondary outcome [21]
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Ischemia-Driven MACE (ID-MACE)
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Assessment method [21]
0
0
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Timepoint [21]
0
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2 years
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Secondary outcome [22]
0
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Ischemia-Driven Target Vessel Failure (ID-TVF)
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Assessment method [22]
0
0
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Timepoint [22]
0
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180 days
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Secondary outcome [23]
0
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Ischemia-Driven Target Vessel Failure (ID-TVF)
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Assessment method [23]
0
0
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Timepoint [23]
0
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1 year
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Secondary outcome [24]
0
0
Ischemia-Driven Target Vessel Failure (ID-TVF)
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Assessment method [24]
0
0
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Timepoint [24]
0
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2 years
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Secondary outcome [25]
0
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Ischemia-Driven Target Vessel Revascularization (ID-TVR)
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Assessment method [25]
0
0
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Timepoint [25]
0
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180 days
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Secondary outcome [26]
0
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Ischemia-Driven Target Vessel Revascularization (ID-TVR)
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Assessment method [26]
0
0
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Timepoint [26]
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1 year
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Secondary outcome [27]
0
0
Ischemia-Driven Target Vessel Revascularization (ID-TVR)
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Assessment method [27]
0
0
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Timepoint [27]
0
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2 years
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Secondary outcome [28]
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Ischemia-Driven Self-Control Vessel Revascularization (ID-SCVR)
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Assessment method [28]
0
0
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Timepoint [28]
0
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180 days
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Secondary outcome [29]
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Ischemia-Driven Self-Control Vessel Revascularization (ID-SCVR)
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Assessment method [29]
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0
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Timepoint [29]
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1 year
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Secondary outcome [30]
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Ischemia-Driven Self-Control Vessel Revascularization (ID-SCVR)
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Assessment method [30]
0
0
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Timepoint [30]
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2 years
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Secondary outcome [31]
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Ischemia-Driven Non-Target, Non-Self-Control Vessel Revascularization (ID-NTNSCVR)
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Assessment method [31]
0
0
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Timepoint [31]
0
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180 days
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Secondary outcome [32]
0
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Ischemia-Driven Non-Target, Non-Self-Control Vessel Revascularization (ID-NTNSCVR)
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Assessment method [32]
0
0
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Timepoint [32]
0
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1 year
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Secondary outcome [33]
0
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Ischemia-Driven Non-Target, Non-Self-Control Vessel Revascularization (ID-NTNSCVR)
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Assessment method [33]
0
0
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Timepoint [33]
0
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2 years
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Secondary outcome [34]
0
0
Ischemia-Driven Target Lesion Revascularization (ID-TLR)
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Assessment method [34]
0
0
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Timepoint [34]
0
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180 days
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Secondary outcome [35]
0
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Ischemia-Driven Target Lesion Revascularization (ID-TLR)
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Assessment method [35]
0
0
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Timepoint [35]
0
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1 year
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Secondary outcome [36]
0
0
Ischemia-Driven Target Lesion Revascularization (ID-TLR)
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Assessment method [36]
0
0
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Timepoint [36]
0
0
2 years
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Secondary outcome [37]
0
0
Scaffold/Stent thrombosis
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Assessment method [37]
0
0
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Timepoint [37]
0
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180 days
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Secondary outcome [38]
0
0
Scaffold/Stent thrombosis
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Assessment method [38]
0
0
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Timepoint [38]
0
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1 year
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Secondary outcome [39]
0
0
Scaffold/Stent thrombosis
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Assessment method [39]
0
0
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Timepoint [39]
0
0
2 years
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Secondary outcome [40]
0
0
Coronary artery endothelial responsiveness
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Assessment method [40]
0
0
Change of vessel diameter by 1) pacing, 2) hand-grip and 3) acetylcholine injection
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Timepoint [40]
0
0
2 years
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Secondary outcome [41]
0
0
Coronary artery cross-sectional compliance and cross-sectional distensibility
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Assessment method [41]
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Cross-sectional compliance is defined as change in area per unit change in pressure; cross-sectional distensibility is defined as compliance/diastolic cross-sectional area.
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Timepoint [41]
0
0
2 years
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Secondary outcome [42]
0
0
Target artery endothelial shear stress distribution
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Assessment method [42]
0
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Wall Shear Stress (WSS) will be determined from flow velocity and blood viscosity
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Timepoint [42]
0
0
2 years
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Secondary outcome [43]
0
0
Wave intensity patterns in the coronary arteries
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Assessment method [43]
0
0
Looking at re-distribution of energy in the blood flow along the coronary artery.
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Timepoint [43]
0
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2 years
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Secondary outcome [44]
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Systolic and diastolic coronary artery impedance
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Assessment method [44]
0
0
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Timepoint [44]
0
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2 years
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Eligibility
Key inclusion criteria
1. Participant must be a male of at least 18 years of age or a female that is
post-menopausal and not on hormone replacement therapy.
2. Participant is able to verbally confirm understanding of risks, benefits and treatment
alternatives and he/she or his/her legally authorized representative must provide
written informed consent prior to any clinical investigation related procedure, as
approved by the appropriate Ethics Committee of the respective clinical site.
3. Participant must have evidence of myocardial ischemia (e.g., stable or unstable
angina, silent ischemia with a positive functional study).
4. Participant must be an acceptable candidate for coronary artery bypass graft (CABG)
surgery.
5. Participant must agree to undergo all clinical investigation plan-required follow-up
visits.
6. Participant must agree not to participate in any other clinical investigation for a
period of 2 years following the index procedure. This includes clinical trials of
medications and invasive procedures. Only questionnaire-based studies are allowed.
Angiographic
1. A single de novo native coronary artery lesion suitable to be treated by either a BVS
or a mDES.
2. Target lesion must be located in a native coronary artery in which the mean proximal
and distal vessel diameter of the target lesion (Dmean) fall within the range of =
2.25 mm and = 3.25 mm and the target lesion length measures = 22 mm as assessed by
IVUS.
3. Target lesion must be located in the main branch of a major epicardial vessel (i.e.,
LAD, LCX, or RCA) with a visually estimated diameter stenosis of = 50% and < 100% with
a TIMI flow of = 1.
4. Participant must have an additional angiographically smooth (< 40% diameter stenosis)
non-target vessel to act as an intra-participant control vessel (self-control vessel).
The self-control vessel must be the main branch of a major epicardial vessel (i.e.,
LAD, LCX, or RCA).
5. Coronary anatomy must be suitable for IVUS, OCT, and pressure and flow wire
instrumentation.
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. Participant has a known diagnosis of spontaneous acute myocardial infarction (AMI)
within 14 days preceding the index procedure.
2. Participant has high-risk acute coronary syndrome (e.g., dynamic ST-T wave change on
ECG or recurrent chest pain/nitrate-unresponsive prolonged chest pain at rest within
48 hours prior to the index procedure).
3. Participant has any evidence of myocardial infarct in the territory subtended by the
proposed target vessel or self-control vessel.
4. Participant has current unstable arrhythmias.
5. Participant has chronic atrial fibrillation.
6. Participant has a known left ventricular ejection fraction (LVEF) < 40%.
7. Participant has received a heart transplant or any other organ transplant or is on a
waiting list for any organ transplant.
8. Participant has previously had CABG or mitral or aortic valve repair/replacement.
9. Participant is receiving or scheduled to receive chemotherapy for malignancy within 30
days prior to or after the index procedure.
10. Participant is receiving immunosuppressant therapy or has known immunosuppressive or
autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus,
etc.).
11. Participant has a chronic systemic condition or medication likely to interfere with
coronary physiology and/or conduit artery function (e.g., chronic inflammatory
condition, chronic renal failure, or chronic obstructive pulmonary disease).
12. Participant has known renal insufficiency.
13. Participant is receiving or scheduled to receive any planned radiotherapy.
14. Participant is receiving chronic anticoagulation therapy (e.g., heparin, coumadin) at
the onset of the clinical investigation.
15. Participant has a known hypersensitivity or contraindication to aspirin,
heparin/bivalirudin, anti-platelet medications specified for use in the study
(clopidogrel, prasugrel and ticlopidine, inclusive), everolimus, poly (L-lactide),
poly (DL-lactide), cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro
polymers, or contrast sensitivity that cannot be adequately pre-medicated.
16. Elective surgery is planned within the first 6 months after the index procedure that
will require discontinuing aspirin, clopidogrel, prasugrel, or ticlopidine.
17. Participant has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of
< 3,000 cells/mm3, or documented or suspected liver disease (including laboratory
evidence of hepatitis) within 7 days prior to the index procedure.
18. Participant has a history of bleeding diathesis or coagulopathy or will refuse blood
transfusions.
19. Participant has had a cerebrovascular accident/stroke (CVA) or transient ischemic
neurological attack (TIA) within the past 6 months.
20. Participant has had a significant gastro-intestinal or significant urinary bleed
within the past 6 months.
21. Participant has extensive peripheral vascular disease that precludes safe 6 French
sheath insertion.
22. Participant has a history of paradoxical exercise-induced vasoconstriction that is
consistent with myocardial bridging in the coronary anatomy.
23. Participant has other medical illness (e.g., cancer or congestive heart failure) or
known history of substance abuse (alcohol, cocaine, heroin etc.) that in the judgment
of the Investigator may cause non-compliance with the clinical investigation plan,
confound the data interpretation or is associated with a limited life expectancy.
24. Participant is currently participating in another clinical investigation that has not
yet reached its primary endpoint.
25. Percutaneous interventions for lesions in the third major epicardial vessel (the one
that does not contain the target or the self-control vessel) were performed within 30
days preceding the index procedure or are planned to be done within 6 months following
the index procedure.
26. Planned PCI procedures in the target vessel (and/or any of its side branches) or the
self-control vessel (and/or any of its side branches) within 2 years following the
index procedure.
27. Participant who does not suspend drugs that will influence vaso-function.
Angiographic Exclusion Criteria
1. Target lesion meets any of the following criteria:
1. Left main location;
2. RCA aorto-ostial location (within 10 mm from expected proximal stent/scaffold
edge);
3. LAD or LCX ostial location (within 10 mm from expected proximal stent/scaffold
edge);
4. Involves a bifurcation with a side branch = 2 mm in diameter, an ostial lesion >
40% stenosed by visual estimation, or a side branch requiring pre-dilatation;
5. Total occlusion (TIMI flow 0) prior to wire crossing;
6. Excessive tortuosity proximal to or within the lesion;
7. Extreme angulation (= 90°) proximal to or within the lesion;
8. Heavy calcification in the lesion;
9. Located in a side branch.
2. Participant has a high probability that a procedure other than pre-dilatation,
scaffold/stent implantation, and post-dilatation (if applicable) will be required at
the time of index procedure for treatment of the target vessel (e.g., atherectomy,
cutting balloon or brachytherapy).
3. The target vessel (and/or any of its side branches) or the self-control vessel (and/or
any of its side branches) contains visible thrombus.
4. The target vessel or the self-control vessel has previously been treated by any PCI
procedures.
5. A side branch of the target vessel or a side branch of the self-control vessel has
received any percutaneous interventions within 30 days prior to the index procedure.
6. Another clinically significant lesion is located in the target vessel (and/or any of
its side branches) or the self-control vessel (and/or any of its side branches) that
may require PCI treatments within 2 years following the index procedure.
7. Participant has evidence of myocardial bridging in the coronary anatomy during the
angiographic evaluation.
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Study design
Purpose of the study
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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
Terminated
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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
1/11/2011
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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
1/04/2013
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Sample size
Target
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Accrual to date
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Final
1
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Health - Heidelberg
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Recruitment hospital [2]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [3]
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Monash Medical Centre - Melbourne
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3168 - Melbourne
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Hong Kong
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Country [2]
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Netherlands
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State/province [2]
0
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Rotterdam
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Country [3]
0
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Singapore
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State/province [3]
0
0
Singapore
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The target enrollment goal for the trial was to enroll 36 subjects. However due to a
challenging protocol inclusion/ exclusion criteria, only one subject was enrolled since the
trial was initiated in June 2011.
To evaluate the following in participants undergoing coronary artery scaffolding/stenting for
significant coronary artery disease:
- The acute (post-implantation) effect of an implanted bioresorbable vascular scaffold
(BVS) or metallic drug eluting stent (mDES) on coronary blood flow and physiological
responsiveness of the target coronary artery
- The long-term (2 years) effect of an implanted BVS or mDES on coronary blood flow and
physiological responsiveness of the target coronary artery
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01308346
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ian Meredith, Prof, MD
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Address
0
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Monash Medical Center
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01308346
Download to PDF