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Sponsored by: |
Cordis Corporation |
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Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00235144 |
The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITY™ stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent. Both stents are mounted on the Raptor® Rapid Exchange Stent Delivery System.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Device: sirolimus-coated Bx Velocity stent Device: uncoated Bx Velocity stent |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | E-Sirius Study: a European, Multi-Center, Randomized, Double-Blind Study of the Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions |
Enrollment: | 353 |
Study Start Date: | March 2001 |
Study Completion Date: | July 2008 |
Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
drug-eluting stent
|
Device: sirolimus-coated Bx Velocity stent
drug-eluting stent
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2: Active Comparator
bare-metal stent
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Device: uncoated Bx Velocity stent
bare-metal stent
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This is a multicenter (up to 35 centers), prospective, randomized double blind study. This study has a 2-arm design assessing the safety and effectiveness of the sirolimus-coated Bx VELOCITY stent to the uncoated Bx VELOCITY stent, both mounted on the Raptor Rapid Exchange Stent Delivery System. A total of 350 patients will be entered in the study and will be randomized on a 1:1 basis. Patients will be either randomized to the sirolimus coated or uncoated BX-VELOCITY stent. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4, 5, 6, 7, and 8 years post-procedure, with all patients undergoing repeat angiography at 8 months. Medical resource use during the 5 years follow-up period will be collected and analyzed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Herzkatheterlabor und Praxisklinik | |
Hamburg, Germany | |
Med. Klinik und Poliklinik | |
Münster, Germany |
Principal Investigator: | Joachim Schofer, MD | Herzkatheterlabor und Praxisklinik, Hamburg |
Principal Investigator: | Günter Breithardt, MD | Med. Klinik und Poliklinik, Münster |
Responsible Party: | Cordis ( Dr. Hans-Peter Stoll ) |
Study ID Numbers: | EC00-07 |
Study First Received: | October 4, 2005 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00235144 |
Health Authority: | Germany: Ethics Commission |
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 |