MedTrace Logo

The European Cobalt STent With Antiproliferative for Restenosis Trial (EuroSTAR Trial)

NCT00974181 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2010-05-17

No results posted yet for this study

Summary

Two consecutive cohorts of subjects were each treated with the CoStar stent loaded with a different paclitaxel dose regimen. The first 145 subjects (Arm I), enrolled between 20 January 2004 and 26 May 2004, were treated with 10 µg paclitaxel and the subsequent 137 subjects (Arm II), enrolled between 15 December 2004 and 9 March 2005, were treated with 30 µg paclitaxel. Both dose formulations eluted over 30 days (in-vitro).

Subjects in both arms completed clinical follow-up at 1, 6 and 12 months post-index procedure, with angiographic follow-up at 6 months as outlined in the original study protocol.

Based on results from previous studies and the initial EuroSTAR Trial results, Conor Medsystems decided to pursue the dosage used in Arm I, 10 μg/30 days, as the commercial dose formulation for the CoStar® stent. The EuroSTAR Trial addendum was proposed for the purpose of evaluating the long-term clinical outcomes of the CoStar stent.

Conditions

  • Treatment of Symptomatic Ischemic Heart Disease

Interventions

DEVICE

Conor Medsystems COSTAR™ stent (10 µg Paclitaxel)

Intervention will consist of percutaneous coronary intervention for treatment of one or more de-novo coronary lesion(s) using standard coronary intervention techniques. Intervention in this arm will include treatment with the CoStar™ Paclitaxel-Eluting Coronary Stent System (10 µg Paclitaxel)

DEVICE

Conor Medsystems COSTAR™ stent (30 µg Paclitaxel)

Intervention will consist of percutaneous coronary intervention for treatment of one or more de-novo coronary lesion(s) using standard coronary intervention techniques. Intervention in this arm will include treatment with the CoStar™ Paclitaxel-Eluting Coronary Stent System (30 µg Paclitaxel)

Sponsors & Collaborators

  • Conor Medsystems

    collaborator INDUSTRY

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • Antonio Colombo, MD · EMO Centro Cuore Columbus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2005-05-31
Completion
2010-03-31

Countries

  • Italy

Study Locations

More Related Trials

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 NCT00974181 on ClinicalTrials.gov