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Sponsored by: |
Cordis Corporation |
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Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00232752 |
The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion late loss in patients with de novo native coronary artery lesions.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Device: 4.0 CYPHER Sirolimus-Eluting Coronary Stent |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Non-Randomized Study of the 4.0mm Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions |
Enrollment: | 100 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | July 2009 |
Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Device: 4.0 CYPHER Sirolimus-Eluting Coronary Stent
4.0 CYPHER Sirolimus-Eluting Coronary Stent
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Brigham & Women's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Mauri Laura, MD | Brigham and Women's Hospital |
Responsible Party: | Brigham & Women's Hospital ( Mauri Laura, MD ) |
Study ID Numbers: | P03-6319 |
Study First Received: | October 3, 2005 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00232752 |
Health Authority: | United States: Food and Drug Administration |
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 |