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

Coronary Artery Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

This was a prospective randomized, double-blind, multicenter safety and efficacy trial. Patients were stratified by presence or absence of medically treated diabetes mellitus and vessel diameter (<3.0 mm or >/=3.0 mm), then randomized 1:1 to receive either the TAXUS Stent or a Control stent. Additional study stents were permitted to optimize outcomes. The study was considered complete (with regard to the primary endpoint) after all patients enrolled had completed the 9 month follow-up.

Enrollment of 1172 patients was planned; 1326 were treated and randomized at 73 centers involving 76 sites by 8 July 2002 with 667 in the TAXUS group and 659 in the Control group. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00292474
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase Phase 2/Phase 3
Start date March 2002
Completion date August 2007
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