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Sponsored by: |
Cordis Corporation |
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Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00232739 |
The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion restenosis in patients with de novo native coronary artery lesions.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Device: 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 2.25mm 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: | May 2009 |
Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Device: CYPHER Sirolimus-eluting Coronary Stent
2.25 Cypher Sirolimus-eluting Coronary Stent
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This is a multicenter (approximately 10 - 14 sites), prospective, non-randomized study. The study is designed to evaluate the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in patients with de novo native coronary artery lesions. A total of 100 patients will be entered in the study. Patients who meet the eligibility criteria will be enrolled into the study. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4 and 5 years post-procedure, with all patients undergoing repeat angiography at 6 months. Approximately 50 patients will be required to have an intravascular ultrasound (IVUS) procedure at baseline and at the 6-month angiographic follow-up.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Lenox Hill Hospital ( Sriram Iyer, MD ) |
Study ID Numbers: | P03-6320 |
Study First Received: | October 3, 2005 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00232739 |
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 |