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Sponsored by: |
Cordis Corporation |
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Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00497172 |
The main objective of this study is to assess the safety and effectiveness of the Sirolimus-eluting stent CYPHERTM and/or updated version in reducing angiographic in-stent late loss in de novo native coronary lesions of diabetic patients as compared to the bare metal Bx SONIC balloon-expandable stent. The secondary objective is to assess cost-effectiveness expressed in incremental cost/life year gained or cost/quality adjusted life year gained at different time points (8 months, 1 year).
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Device: CYPHER Sirolimus-eluting stent Device: Bx SONIC bare metal stent |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Italian Multicenter, Randomized, Single Blind Study of the Sirolimus Eluting Stent in the Treatment Of Diabetic Patients With De Novo Coronary Artery Lesions |
Enrollment: | 150 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | April 2009 |
Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
drug-eluting stent
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Device: CYPHER Sirolimus-eluting stent
drug-eluting stent
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2: Active Comparator
bare-metal stent
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Device: Bx SONIC bare metal stent
bare-metal stent
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This is a multicenter (11 centers), prospective, randomized single blind study. This study has a 2-arm design assessing the safety and effectiveness of the Sirolimus-eluting stent CYPHERTM and/or updated version to the bare metal Bx SONICTM stent. A total of 250 patients will be entered in the study and will be randomized on a 1:1 basis. Patients who meet the eligibility criteria will be either randomized to the Sirolimus-eluting stent or the bare metal Bx SONIC stent. The investigator cannot be blind because the outer appearance of the system for the implant of the Sirolimus-eluting stent differs from that of the bare metal stent and will therefore immediately be recognized by the surgeon. However the patient will not know which stent will be implanted. Patients will be followed at 30 days, 9 and 12 months post-procedure, with all patients undergoing repeat angiography at 8 months.
Additionally, medical costs associated with the index hospitalization and length of stay, and repeat hospitalizations and costs associated with other relevant medical resource use during the 1 year 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:
Responsible Party: | Cordis ( Dr. Hans-Peter Stoll ) |
Study ID Numbers: | CRDIT 00-02/02 |
Study First Received: | July 4, 2007 |
Last Updated: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00497172 History of Changes |
Health Authority: | Italy: competent authorities |
Arterial Occlusive Diseases Sirolimus Heart Diseases Immunologic Factors Clotrimazole Miconazole Myocardial Ischemia Tioconazole Diabetes Mellitus |
Vascular Diseases Ischemia Arteriosclerosis Immunosuppressive Agents Coronary Disease Anti-Bacterial Agents Antifungal Agents Coronary Artery Disease |
Arterial Occlusive Diseases Sirolimus Anti-Infective Agents Heart Diseases Immunologic Factors Antineoplastic Agents Myocardial Ischemia Physiological Effects of Drugs Vascular Diseases Arteriosclerosis |
Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Coronary Disease Anti-Bacterial Agents Antifungal Agents Therapeutic Uses Cardiovascular Diseases Coronary Artery Disease |