At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 100 enrolled

Drug / intervention

SYNERGYdevice

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.

Search/NCT01787799

NCT01787799Phase 3Completed

Compare CT.gov

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)

Boston Scientific Corporation·interventional·Posted Feb 11, 2013·Updated Mar 16, 2016

In Brief

A Phase 3 clinical trial evaluating SYNERGY for Atherosclerotic Lesion(s). Completed, enrolled 100 participants across 13 sites in 4 countries.

Detailed 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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAtherosclerotic Lesion(s)

CountriesAustralia, Japan, New Zealand, Singapore

CollaboratorsBeth Israel Deaconess Medical Center, Medstar Health Research Institute, Quintiles, Inc., Medidata Solutions

Timeline

Phase 3CompletedFinished

20132014201520162017201820192020202120222023202420252026

First PostedFeb 2013

Enrollment StartMar 2013

Primary CompletionAug 2014

Study CompletionOct 2014

TodayJul 2026

First PostedFeb 11, 2013

Enrollment StartMar 1, 2013

Primary CompletionAug 1, 2014

Study CompletionOct 1, 2014

TodayJul 2, 2026

Enrollment to primary: 1.4 yearsPosted 13.4 years ago

Interventions

SYNERGYdevice

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.