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Sponsored by: |
Boston Scientific Corporation |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00299026 |
The clinical investigation is an international, prospective, double-blind, randomized safety and efficacy study. The purpose of this study is to evaluate the safety and performance of the NIRx(TM) Paclitaxel-Coated Stent (1.0µg/mm2 of paclitaxel incorporated into slow- and moderate-release formulation of a triblock copolymer carrier system)in patients who present for stenting of de novo lesions of a native coronary artery.
Condition | Intervention | Phase |
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Coronary Artery Disease |
Device: NIRx(TM) Paclitaxel-Coated Conformer Coronary Stent System |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | TAXUS II: A Randomized, Double-Blind, Controlled Study of the Safety and Performance of the NIRx™ Paclitaxel-Coated Conformer Coronary Stent |
Estimated Enrollment: | 532 |
Study Start Date: | June 2001 |
Study Completion Date: | February 2007 |
Primary Completion Date: | May 2003 (Final data collection date for primary outcome measure) |
The primary objective of this study is to evaluate the safety and performance of coronary artery stenting with the NIRx(TM) Paclitaxel-Coated Stent (1.0µg/mm2 of paclitaxel incorporated into slow- and moderate-release formulation of a triblock copolymer carrier system) for the treatment of de novo lesions in native vessels. Patients in 2 sequential cohorts will be randomised to receive either the NIRx(TM) Paclitaxel-Coated Stent or the uncoated control stent. In cohort 1, the slow-release formulation NIRx(TM) Paclitaxel-Coated Stent will be studied. If the safety profile is acceptable, the moderate-release formulation NIRx(TM) Paclitaxel-Coated Stent will be studied in Cohort 2. In each f the 2 cohorts, 133 patients will be treated with the NIRx(TM) paclitaxel-Coated Stent and 133 with the uncoated control stent (1.1 ratio), for a total of 532 patients in study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
General Inclusion Criteria:
Angiographic Inclusion Criteria:
General Exclusion Criteria:
Angiographic Exclusion Criteria:
Responsible Party: | Boston Scientific ( Thomas Naeschen, PhD ) |
Study ID Numbers: | TAXUS II, S2003 |
Study First Received: | March 3, 2006 |
Last Updated: | August 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00299026 History of Changes |
Health Authority: | Italy: National Institute of Health |
Coronary Artery Disease Percutaneous Coronary Intervention Stent Implant Drug-coated Stent |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Paclitaxel Myocardial Ischemia Tubulin Modulators |
Vascular Diseases Antimitotic Agents Arteriosclerosis Ischemia Antineoplastic Agents, Phytogenic Coronary Artery Disease |
Arterial Occlusive Diseases Heart Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myocardial Ischemia Mitosis Modulators Vascular Diseases Arteriosclerosis Antimitotic Agents |
Pharmacologic Actions Coronary Disease Paclitaxel Therapeutic Uses Tubulin Modulators Cardiovascular Diseases Antineoplastic Agents, Phytogenic Coronary Artery Disease |