EVOLVE II

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)

EVOLVE II [NCT01665053]

Description: (Enrolling DM substudy only) 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).

 

Device: SYNERGY; Device: PROMUS Element Plus

Primary Investigator: Sarembock

Drug/Device Information
SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System is based on Element™ stent platform
Utilizes a bioabsorbable poly(DL-lactide-co-glycolide) (PLGA) polymer to deliver everolimus
1:1 randomized SYNERGY™ to PROMUS™ Element Plus (control), DM substudy nonrandomized
Boston Scientific Corporation