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Sponsored by: |
Cordis Corporation |
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Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00233766 |
The objective of this study is to assess the performance and safety of two reduced sirolimus doses on the Bx VELOCITY Balloon-Expandable stent, mounted on the Raptorâ rapid exchange (RX) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.
Condition | Intervention | Phase |
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Coronary Artery Disease |
Device: Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Evaluation of Two Reduced Sirolimus Doses on the BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions(REDOX) |
Estimated Enrollment: | 60 |
Study Start Date: | September 2002 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Instituto Dante Pazzanese de Cardiologia ( J. E. Sousa, MD ) |
Study ID Numbers: | P02-6314 |
Study First Received: | October 4, 2005 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00233766 |
Health Authority: | Brazil: National Committee of Ethics in Research |
Sirolimus Arterial Occlusive Diseases Coronary Disease Heart Diseases Clotrimazole Miconazole |
Myocardial Ischemia Tioconazole Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents Therapeutic Uses |
Physiological Effects of Drugs Cardiovascular Diseases Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |