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

NCT01787799 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-03-16

Study results available
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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

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.

Sponsors & Collaborators

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • Medstar Health Research Institute

    collaborator OTHER

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Medidata Solutions

    collaborator INDUSTRY

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Ian Meredith, Professor · Monash Medical Centre-Clayton Campus, 246 Clayton Road, 3168 Clayton, Victoria, Australia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-08-31
Completion
2014-10-31

Countries

  • Australia
  • Japan
  • New Zealand
  • Singapore

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01787799 on ClinicalTrials.gov