NCT01665053

The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,684 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

A concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy and a consecutive, non-randomized, single-arm, Diabetes substudy will also enroll under the EVOLVE II protocol.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	PROMUS Element Plus	A drug eluting coronary stent system
DEVICE	SYNERGY	A drug eluting coronary stent system

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-09-01
• Completion: 2018-12-22
• First posted: 2012-08-15
• Last updated: 2019-01-30
• Results posted: 2016-01-07

Locations

126 sites across 16 countries: United States, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Italy, Japan, Latvia, Netherlands, New Zealand, Poland, Singapore, Spain