NCT01787799

EVOLVE II QCA: A Prospective, Multicenter Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)

EVOLVE II QCA: A Prospective, Multicenter Trial to Assess 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: 100 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate 9 month angiographic and intravascular ultrasound (IVUS) data for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) in 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).

Conditions

• Atherosclerotic Lesion(s)

Interventions

Type	Name	Description
DEVICE	SYNERGY	Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating.

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-08-01
• Completion: 2014-10-01
• First posted: 2013-02-11
• Last updated: 2016-03-16
• Results posted: 2016-03-16

Locations

13 sites across 4 countries: Australia, Japan, New Zealand, Singapore