Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Percutaneous Coronary Intervention, Stent Implant, Drug-coated Stent
Brief summary
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.
Detailed description
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.
Interventions
DEVICETAXUS Express Paclitaxel-Eluting Coronary Stent System
Paclitaxel-Eluting Coronary Stent System
DEVICEControl stent
control stent
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* General Inclusion Criteria 1. Patient \>or= 18 years old 2. Eligible for percutaneous coronary intervention 3. Documented stable angina pectoris or unstable angina pectoris with documented ischemia or documented silent ischemia 4. Acceptable candidate for CABG 5. Patient (or legal guardian) understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed 6. Willing to comply with all specified follow-up evaluations * Angiographic Inclusion Criteria 1. Target lesion located within a single native coronary vessel 2. Target lesion randomized to treatment with the study device may be composed of multiple lesions but must be completely coverable by up to 2 study stents (maximum allowable stent length of 48 mm). 3. Cumulative target lesion length is \>or= 18 mm and \<or= 40 mm (visual estimate) 4. RVD of \>or= 2.5 mm to \<or= 3.75 mm (visual estimate) 5. Target lesion diameter stenosis \>or=50% (visual estimate) 6. Target lesion is de novo
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of TVR 9 months after index procedure | 9 Months |
Secondary
| Measure | Time frame |
|---|---|
| Stent thrombosis rate. | 5 Years |
| Target Vessel Failure. | 5 years |
| Clinical procedural success. | Post procedure |
| • 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). | 5 years |
| • Additional angiographic endpoints at 9 month angiographic follow-up | 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. | 9 months |
| Binary restenosis rate. | 9 months |
Countries
Germany
Outcome results
None listed