At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,684 enrolled
Drug / intervention
PROMUS Element Plus +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
EVOLVE II: A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the Treatment of Atherosclerotic Lesion(s)
In Brief
A Phase 3 clinical trial evaluating PROMUS Element Plus and SYNERGY for Coronary Artery Disease. Completed, enrolled 1,684 participants across 126 sites in 16 countries.
Detailed Summary
The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesAustralia, Austria, Belgium, Canada, Denmark, Finland, France, Italy, Japan, Latvia, Netherlands, New Zealand, Poland, Singapore, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartNov 2012
Primary CompletionSep 2014
Study CompletionDec 2018
TodayJul 2026
First PostedAug 15, 2012
Enrollment StartNov 1, 2012
Primary CompletionSep 1, 2014
Study CompletionDec 22, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.9 years ago
Interventions
PROMUS Element Plusdevice
A drug eluting coronary stent system
SYNERGYdevice
A drug eluting coronary stent system