A Randomized, Double-blind Study to Assess Paclitaxel-eluting Stents in Treatment of Longer Lesions (TAXUS VI)
|Coronary Artery Disease||Device: TAXUS Express Paclitaxel-Eluting Coronary Stent System Device: Control stent||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
|Official Title:||TAXUS VI - A Randomized, Double-blind Study to Assess Paclitaxel-eluting Stents in Treatment of Longer Lesions|
- Rate of TVR 9 months after index procedure [ Time Frame: 9 Months ]
- • Rates of composite Major Adverse Cardiac Events (MACE) and the individual components of MACE, assessed at 1, 3, 6 and 9 months after the study procedure and annually for 5 years (i.e., 1, 2, 3, 4, and 5 years after the study procedure). [ Time Frame: 5 years ]
- Stent thrombosis rate. [ Time Frame: 5 Years ]
- Target Vessel Failure. [ Time Frame: 5 years ]
- Clinical procedural success. [ Time Frame: Post procedure ]
- Binary restenosis rate. [ Time Frame: 9 months ]
- • Additional angiographic endpoints at 9 month angiographic follow-up [ Time Frame: 9 months ]
- IVUS assessment in a subset of approximately 200 patients. At the baseline procedure (post-procedural) and at 9 month follow-up the absolute neointimal volume and the change in neointimal volume from post-procedure to follow-up will be analysed. [ Time Frame: 9 months ]
|Study Start Date:||May 2002|
|Study Completion Date:||February 2008|
|Primary Completion Date:||October 2003 (Final data collection date for primary outcome measure)|
|Experimental: Arm 1||
Device: TAXUS Express Paclitaxel-Eluting Coronary Stent System
Paclitaxel-Eluting Coronary Stent System
|Active Comparator: Arm 2||
Device: Control stent
The ultimate goal of a paclitaxel eluting stent system 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 VI trial is to study the safety and efficacy of the TAXUS(TM)Stent under controlled trial circumstances and targets patients with a higher risk of target lesion revascularisation and restenosis. The study population will include longer lesions, smaller diameter vessels, multiple lesions in the same vessel, and allows for the use of up to 2 randomized study stents.
The clinical investigation will evaluate the safety and effectiveness of the TAXUS(TM)Stent with 1 µg/mm2 (loaded drug/stent surface area) of paclitaxel incorporated into a moderate rate-release formulation of a triblock copolymer carrier system for treatment of de novo coronary artery lesions.
Patients are stratified by site and presence or absence of medically treated diabetes mellitus and then randomized to receive either the TAXUS(TM)Stent or the uncoated EXPRESS(TM)stent.
The primary objective of the study is to show superior 9-month target vessel revascularization (TVR) rate for TAXUS(TM) Stent compared to uncoated Express(TM)control stent.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297804
|Siegburg, Germany, 53721|
|Principal Investigator:||Eberhard Grube, MD||HELIOS Clinic Siegburg, Germany|