TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent
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.
Coronary Artery Disease
Device: percutaneous coronary intervention
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent|
- The primary objective of this study is to evaluate the safety and effectiveness of the TAXUS Stent System with 1 ug/mm2 (loaded drug/stent surface area) of paclitaxel incorporated into a slow rate-release formulation of a triblock copolymer carrier syst
- Secondary endpoints include the following:
- • Rates of composite MACE and the individual components of MACE (MI, TVR, Cardiac Death), assessed at 1, 4 and 9 months after the index procedure and annually for 5 more years (i.e., 1, 2, 3, 4, and 5 years after the index procedure).
- • Stent thrombosis rate
- • Target Vessel Failure
- • Clinical procedural success
- • Binary restenosis rate
|Study Start Date:||March 2002|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
|Experimental: TAXUS Express||Device: percutaneous coronary intervention|
|Placebo Comparator: Express Bare||Device: percutaneous coronary intervention|
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.
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Gregg W Stone, MD||Columbia Hospital|
|Principal Investigator:||Stephen G Ellis, MD||The Cleveland Clinic|