The clinical investigation is an international, prospective, multi-center, double-blind, randomized safety and efficacy trial. The purpose of this study is to evaluate the safety and effectiveness of the TAXUS(TM)Stent System with 1µg/mm2 (loaded drug/stent surface area) of paclitaxel incorporated into a moderate rate-release formulation of triblock copolymer carrier system in patients with a higher risk of target lesion revascularisation and restenosis.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
448
Paclitaxel-Eluting Coronary Stent System
control stent
HELIOS Clinic
Siegburg, Germany
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
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