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DEFINITIONS
Trial Review
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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/NCT01498692
Registration number
NCT01498692
Ethics application status
Date submitted
20/12/2011
Date registered
23/12/2011
Date last updated
26/03/2019
Titles & IDs
Public title
The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions in Small Vessels
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Scientific title
PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions - Small Vessel Sub-trial
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Secondary ID [1]
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0
S2046A
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Universal Trial Number (UTN)
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Trial acronym
PLATINUM SV
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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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0
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Condition category
Condition code
Cardiovascular
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0
0
0
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - PROMUS Element Coronary Stent System
Experimental: PROMUS Element - Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
Treatment: Devices: PROMUS Element Coronary Stent System
PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating)
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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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Target Lesion Failure (TLF)
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Assessment method [1]
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Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. The primary analysis set for the non-inferiority testing of the primary endpoint is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set.
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Timepoint [1]
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12 Months
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Secondary outcome [1]
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Target Lesion Failure (TLF)
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Assessment method [1]
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Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
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Timepoint [1]
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6 Months
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Secondary outcome [2]
0
0
Target Lesion Failure (TLF)
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Assessment method [2]
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Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
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Timepoint [2]
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0
30 Days
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Secondary outcome [3]
0
0
Target Vessel Failure (TVF)
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Assessment method [3]
0
0
Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI;Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
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Timepoint [3]
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0
12 Months
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Secondary outcome [4]
0
0
Target Vessel Failure (TVF)
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Assessment method [4]
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Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI;Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
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Timepoint [4]
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0
6 Months
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Secondary outcome [5]
0
0
Target Vessel Failure (TVF)
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Assessment method [5]
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Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI;Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
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Timepoint [5]
0
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30 Days
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Secondary outcome [6]
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Myocardial Infarction (MI) Related to the Target Vessel
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Assessment method [6]
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New Q-waves in =2 leads lasting =0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus =one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN
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Timepoint [6]
0
0
12 Months
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Secondary outcome [7]
0
0
Myocardial Infarction (MI) Related to the Target Vessel
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Assessment method [7]
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0
New Q-waves in =2 leads lasting =0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus =one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN
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Timepoint [7]
0
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6 months
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Secondary outcome [8]
0
0
Myocardial Infarction (MI) Related to the Target Vessel
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Assessment method [8]
0
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New Q-waves in =2 leads lasting =0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus =one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN
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Timepoint [8]
0
0
30 days
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Secondary outcome [9]
0
0
All Cause Mortality
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Assessment method [9]
0
0
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Timepoint [9]
0
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12 months
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Secondary outcome [10]
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All Cause Mortality
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Assessment method [10]
0
0
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Timepoint [10]
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6 months
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Secondary outcome [11]
0
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All Cause Mortality
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Assessment method [11]
0
0
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Timepoint [11]
0
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30 days
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Secondary outcome [12]
0
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Cardiac Death Related to the Target Vessel
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Assessment method [12]
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Defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above.
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Timepoint [12]
0
0
12 months
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Secondary outcome [13]
0
0
Cardiac Death Related to the Target Vessel
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Assessment method [13]
0
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Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above
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Timepoint [13]
0
0
6 months
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Secondary outcome [14]
0
0
Cardiac Death Related to the Target Vessel
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Assessment method [14]
0
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Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above
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Timepoint [14]
0
0
30 days
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Secondary outcome [15]
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Target Lesion Revascularization (TLR)
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Assessment method [15]
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Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
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Timepoint [15]
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0
12 months
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Secondary outcome [16]
0
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Target Lesion Revascularization (TLR)
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Assessment method [16]
0
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Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
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Timepoint [16]
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6 months
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Secondary outcome [17]
0
0
Target Lesion Revascularization TLR)
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Assessment method [17]
0
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Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
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Timepoint [17]
0
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30 days
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Secondary outcome [18]
0
0
Target Vessel Revascularization (TVR)
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Assessment method [18]
0
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Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis =50% by quantitative coronary angiography in the target vessel, including the target lesion.
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Timepoint [18]
0
0
12 months
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Secondary outcome [19]
0
0
Target Vessel Revascularization (TVR)
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Assessment method [19]
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Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis =50% by quantitative coronary angiography in the target vessel, including the target lesion.
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Timepoint [19]
0
0
6 months
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Secondary outcome [20]
0
0
Target Vessel Revascularization (TVR)
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Assessment method [20]
0
0
Any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis =50% by quantitative coronary angiography in the target vessel, including the target lesion.
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Timepoint [20]
0
0
30 days
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Secondary outcome [21]
0
0
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC)Definition
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Assessment method [21]
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DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)
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Timepoint [21]
0
0
24 hours
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Secondary outcome [22]
0
0
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
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Assessment method [22]
0
0
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)
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Timepoint [22]
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>24 hr-30 days
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Secondary outcome [23]
0
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Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
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Assessment method [23]
0
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DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)
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Timepoint [23]
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>30 days-1 year
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Secondary outcome [24]
0
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Acute Technical Success
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Assessment method [24]
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Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent
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Timepoint [24]
0
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During the index procedure (minutes)
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Secondary outcome [25]
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Clinical Procedural Success
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Assessment method [25]
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Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital MI, TVR, or cardiac death.
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Timepoint [25]
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Duration of Hospital Stay (average 1-2 days)
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Eligibility
Key inclusion criteria
- Patient must be at least 18 years of age
- Patient (or legal guardian) understands study requirements and treatment procedures
and provides written informed consent before any study-specific tests or procedures
are performed
- For patients less than 20 years of age enrolled at a Japanese site, patient and
patient's legal representative must provide written informed consent before any
study-specific tests or procedures are performed
- Patient is eligible for percutaneous coronary intervention (PCI)
- Patient has documented stable angina pectoris or documented silent ischemia; or
unstable angina pectoris
- Patient is an acceptable candidate for coronary artery bypass grafting (CABG)
- Patient has a left ventricular ejection fraction (LVEF) >=30% as measured within 30
days prior to enrollment
- Patient is willing to comply with all protocol-required follow-up evaluations
Angiographic Inclusion Criteria (visual estimate):
- Target lesion must be a de novo lesion located in a native coronary artery with a
visually estimated reference vessel diameter =2.25 mm and <2.5 mm. Target lesion length
must measure =28 mm by visual estimate. Target lesion must be located in a major coronary
artery or branch with visually estimated stenosis =50% and <100% with Thrombolysis In
Myocardial Infarction (TIMI) flow >1.
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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
- Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with
acute myocardial infarction (MI)
- Patient has had a known diagnosis of recent MI (ie, within 72 hours prior to index
procedure) and has elevated enzymes at time of index procedure as follows.
- Patients are excluded if any of the following criteria are met at time of the
index procedure.
- If creatine kinase-myoglobin band (CK-MB) >2× upper limit of normal (ULN),
the patient is excluded regardless of CK Total.
- If CK-MB is 1-2× ULN, the patient is excluded if the CK Total is >2× ULN.
- If CK Total/CK MB are not used and Troponin is, patients are excluded if the
following criterion is met at time of index procedure.
- Troponin >1× ULN with at least one of the following.
- Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (eg,
>1 mm ST segment elevation or depression in consecutive leads or new left bundle
branch block [LBBB]);
- Development of pathological Q waves in the ECG; or
- Imaging evidence of new loss of viable myocardium or new regional wall motion
abnormality.
Note: For patients with unstable angina or patients who have had a recent MI, CK Total/CK
MB (or Troponin if CK Total/CK MB are not used) must be documented prior to
enrolling/randomizing the patient.
- Patient has received an organ transplant or is on a waiting list for an organ
transplant
- Patient is receiving or scheduled to receive chemotherapy within 30 days before or
after index procedure
- Patient is receiving oral or intravenous immunosuppressive therapy (ie, inhaled
steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune
disease (eg, human immunodeficiency virus, systemic lupus erythematosus, but not
including diabetes mellitus)
- Patient is receiving chronic (>=72 hours) anticoagulation therapy (eg, heparin,
coumadin) for indications other than acute coronary syndrome
- Patient has platelet count <100,000 cells/mm3 or >700,000 cells/mm3
- Patient has white blood cell (WBC) count <3,000 cells/mm3
- Patient has documented or suspected liver disease, including laboratory evidence of
hepatitis
- Patient is on dialysis or has known renal insufficiency (ie, estimated creatinine
clearance <50 ml/min by the Cockcroft Gault formula, or [(140-age)*lean body weight
(in kg)]/[plasma creatinine (mg/dl)*72])
- Patient has history of bleeding diathesis or coagulopathy or will refuse blood
transfusions
- Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA)
within past 6 months, or has any permanent neurologic defect that may cause
non-compliance with the protocol
- Target vessel(s) or side branch has been treated with any type of PCI (eg, balloon
angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to index
procedure
- Target vessel(s) has been treated within 10 mm proximal or distal to target lesion (by
visual estimate) with any type of PCI (eg, balloon angioplasty, stent, cutting
balloon, atherectomy) at any time prior to index procedure
- Non-target vessel or side branch has been treated with any type of PCI (eg, balloon
angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to index
procedure
- Planned or actual target vessel(s) treatment with an unapproved device, directional or
rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction
catheter immediately prior to stent placement
- Planned PCI or CABG after index procedure
- Patient previously treated at any time with coronary intravascular brachytherapy
- Patient has a known allergy to the study stent system or protocol-required concomitant
medications (eg, stainless steel, platinum, cobalt, chromium, nickel, tungsten,
acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot
be adequately premedicated
- Patient has active peptic ulcer or active gastrointestinal (GI) bleeding
- Patient has one of the following.
- Other serious medical illness (eg, cancer, congestive heart failure) that may
reduce life expectancy to less than 24 months
- Current problems with substance abuse (eg, alcohol, cocaine, heroin, etc.)
- Planned procedure that may cause non-compliance with protocol or confound data
interpretation
- Patient is participating in another investigational drug or device clinical trial that
has not reached its primary endpoint
- Patient intends to participate in another investigational drug or device clinical
trial within 12 months after index procedure
- Patient with known intention to procreate within 12 months after index procedure
(Women of child-bearing potential who are sexually active must agree to use a reliable
method of contraception from the time of screening through 12 months after the index
procedure.)
- Patient is a woman who is pregnant or nursing (A pregnancy test must be performed
within 7 days prior to the index procedure in women of child-bearing potential)
- Patient has more than 2 target lesions, or more than 1 target lesion and 1 non-target
lesion, which will be treated during the index procedure
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
1/02/2009
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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
1/05/2015
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Sample size
Target
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Accrual to date
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Final
94
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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0
St. Vincent's Hospital - Fitzroy
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Recruitment hospital [2]
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0
Monash Medical Centre - Clayton
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Recruitment postcode(s) [1]
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0
3065 - Fitzroy
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Recruitment postcode(s) [2]
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0
VIC 3168 - Clayton
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Illinois
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Kentucky
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Michigan
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Minnesota
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Country [7]
0
0
United States of America
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State/province [7]
0
0
North Carolina
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Ohio
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Oklahoma
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Texas
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Country [11]
0
0
Belgium
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State/province [11]
0
0
Genk
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Country [12]
0
0
Belgium
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State/province [12]
0
0
Leuven
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Country [13]
0
0
France
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State/province [13]
0
0
Cedex 9
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Country [14]
0
0
France
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State/province [14]
0
0
Toulouse
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Country [15]
0
0
Japan
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State/province [15]
0
0
Kanagawa-ken
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Country [16]
0
0
Japan
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State/province [16]
0
0
Osaka
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Country [17]
0
0
New Zealand
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State/province [17]
0
0
Takapuna
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boston Scientific Corporation
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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 purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™
Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo
atherosclerotic coronary artery lesions. The lesions can be located in vessels that are
smaller than average-sized.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01498692
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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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Peter M Maurer, MPH
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Address
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Boston Scientific Corporation
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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/NCT01498692
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