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Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries

NCT00148356 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 401

Last updated 2011-04-01

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the safety and efficacy of the ZoMaxx drug-eluting stent in patients with blockage of native coronary arteries. The study is designed to demonstrate non-inferiority to the TAXUS Express2 Paclitaxel-Eluting Stent that has proven superior to bare metal stents and is a recognized standard of care.

Conditions

Interventions

DEVICE

ZoMaxx™ Drug-Eluting Coronary Stent System

Drug eluting stent implantation stent in the treatment of coronary artery disease.

DEVICE

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System

Drug eluting stent implantation stent in the treatment of coronary artery disease.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Bernard Chevalier, M.D. · Centre Cardiologique du Nord

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2006-05-31
Completion
2010-10-31

Countries

  • Australia
  • Belgium
  • Denmark
  • France
  • Germany
  • Netherlands
  • New Zealand
  • Portugal
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00148356 on ClinicalTrials.gov