At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 100 enrolled
Drug / intervention
SYNERGY 48 mmdevice
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 48: A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of the SYNERGY 48 mm Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
In Brief
A Phase 3 clinical trial evaluating SYNERGY 48 mm for Coronary Artery Disease. Completed, enrolled 100 participants across 15 sites in 4 countries.
Detailed Summary
EVOLVE 48 is a prospective, open label, single arm, multi-center trial. The purpose of this study is to assess the FDA requirement for safety and effectiveness of the SYNERGY 48 mm Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) \> 34 mm and ≤ 44 mm in length (by visual estimate) in native coronary arteries ≥2.5 mm to ≤4.0 mm in diameter (by visual estimate).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesLatvia, New Zealand, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartApr 2018
Primary CompletionJan 2020
Study CompletionJan 2021
TodayJul 2026
First PostedNov 22, 2017
Enrollment StartApr 12, 2018
Primary CompletionJan 16, 2020
Study CompletionJan 8, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.6 years ago
Interventions
SYNERGY 48 mmdevice
A drug eluting coronary stent system