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Sponsored by: |
Cordis Corporation |
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Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00495898 |
The main objective of this study is to assess the safety and effectiveness of the CYPHER sirolimus-eluting stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients with manifest diabetes mellitus. Both stents are mounted on the Raptorâ Rapid Exchange Stent Delivery System.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Device: CYPHER sirolimus-eluting stent Device: uncoated Bx VELOCITY balloon-expandable stent |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A German Multicenter, Randomized, Controlled, Open-Label Study of the Cypher Sirolimus-Eluting Stent in the Treatment of Diabetic Patients With De Novo Native Coronary Artery Lesions |
Enrollment: | 200 |
Study Start Date: | November 2002 |
Estimated Study Completion Date: | November 2009 |
Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
CYPHER sirolimus-eluting stent
|
Device: CYPHER sirolimus-eluting stent
drug-eluting stent
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2: Active Comparator
uncoated Bx VELOCITY balloon-expandable stent
|
Device: uncoated Bx VELOCITY balloon-expandable stent
bare metal stent
|
This is a multicenter (19 sites), prospective, 2 arm randomized study designed to assess the safety and effectiveness of the CYPHER sirolimus-eluting stent as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients with manifest diabetes mellitus. Patients with de novo native coronary artery lesions <= 42 mm in length and >=2.5mm and <=3.5mm in diameter (by visual estimate) will be included in the study. A total of 190 patients will be entered and randomly allocated to the CYPHERTM sirolimus-eluting stent or the uncoated Bx VELOCITY balloon-expandable stent at a 1:1 ratio. Patients will be followed for 12 months post-procedure, with all patients having a repeat angiography at 8 months (± 1 month).
It is anticipated the total duration of the study will be 18 months: 6 months to complete patient enrollment and 12 months for follow up.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
None
Responsible Party: | Cordis ( Dr. Hans-Peter Stoll ) |
Study ID Numbers: | CRDDE-001 |
Study First Received: | July 2, 2007 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00495898 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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 |