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TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent

NCT00292474 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1326

Last updated 2008-10-08

No results posted yet for this study

Summary

The ultimate goal of a paclitaxel eluting stent system (TAXUS stent) is to prevent restenosis by blunting the initial response to stent implant injury and sustaining the arrested response until vascular healing has taken place.

The purpose of the TAXUS IV-SR trial is to study the safety and efficacy of the TAXUS Stent under controlled trial circumstances used in the treatment of new coronary artery lesions (heart blockages) This clinical investigation will evaluate the safety and effectiveness of the TAXUS Stent with 1 ug/mm2 (loaded drug/stent surface area) of paclitaxel incorporated into a slow rate-release formulation of a triblock copolymer carrier system for treatment of new coronary artery lesions.

Conditions

Interventions

DEVICE

percutaneous coronary intervention

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Gregg W Stone, MD · Columbia Hospital

  • Stephen G Ellis, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States

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 NCT00292474 on ClinicalTrials.gov