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Sponsored by: |
Boston Scientific Corporation |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00297804 |
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.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Device: TAXUS Express Paclitaxel-Eluting Coronary Stent System Device: Control stent |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | TAXUS VI - A Randomized, Double-Blind Study to Assess Paclitaxel-Eluting Stents in Treatment of Longer Lesions |
Enrollment: | 448 |
Study Start Date: | May 2002 |
Estimated Study Completion Date: | February 2008 |
Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Device: TAXUS Express Paclitaxel-Eluting Coronary Stent System
Paclitaxel-Eluting Coronary Stent System
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Arm 2: Active Comparator |
Device: Control stent
control stent
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
General Inclusion Criteria
Angiographic Inclusion Criteria
Exclusion Criteria:
General Exclusion Criteria:
Angiographic Exclusion Criteria
Responsible Party: | Boston Scientific ( Thomas Naeschen ) |
Study ID Numbers: | S2009, TAXUS VI |
Study First Received: | February 27, 2006 |
Last Updated: | February 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00297804 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Coronary Artery Disease Percutaneous Coronary Intervention Stent Implant Drug-coated Stent |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Paclitaxel Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Mitosis Modulators Tubulin Modulators |
Cardiovascular Diseases Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |