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Sponsored by: |
Cordis Corporation |
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Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00233714 |
The main objective of this study is to assess safety and effectiveness of double dose sirolimus-eluting Bx VELOCITY stents in diabetic patients with a de novo native coronary lesion, as compared to single dose sirolimus-eluting Bx VELOCITY™ stents.
Condition | Intervention | Phase |
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Coronary Artery Disease |
Device: CYPHER Sirolimus-Eluting Coronary Stent |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Feasibility Study of the Double Dose or Single Dose Sirolimus-Eluting BX VELOCITY Balloon-Expandable Stent for the Treatment of Diabetic Patients With de Novo Native Coronary Artery Lesions(3D) |
Enrollment: | 56 |
Study Start Date: | May 2003 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Single-dose Sirolimus-Eluting Coronary stent
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Device: CYPHER Sirolimus-Eluting Coronary Stent
Single dose Sirolimus-Eluting coronary stent
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2: Active Comparator
Double-dose Sirolimus-Eluting Coronary stent
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Device: CYPHER Sirolimus-Eluting Coronary Stent
Double-dose 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:
Treatment of one lesion in a native coronary artery. The treated lesion will be the one with the highest % diameter stenosis by visual estimate.
Additional study stents may be used for procedural complications such as dissections. Multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. If other non-target lesions are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;
Exclusion Criteria:
Responsible Party: | Cordis ( Sid Cohen, MD, VP ) |
Study ID Numbers: | P03-6318 |
Study First Received: | October 4, 2005 |
Last Updated: | March 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00233714 History of Changes |
Health Authority: | Israel: Ministry of Health; Italy: Ministry of Health; Brazil: National Committee of Ethics in Research |
Arterial Occlusive Diseases Sirolimus Heart Diseases Immunologic Factors Clotrimazole Myocardial Ischemia Miconazole Tioconazole |
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 |