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Sponsored by: |
Cordis Corporation |
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Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00232791 |
The main objective of this study is to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the CYPHER ™ Sirolimus-eluting Coronary Stent.
Condition | Intervention | Phase |
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Coronary Artery Disease |
Device: Cypher Select Device: Cypher |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Study With the CYPHER SELECT™ Sirolimus-Eluting Balloon-Expandable Coronary Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions. |
Enrollment: | 102 |
Study Start Date: | January 2004 |
Study Completion Date: | March 2005 |
Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
CYPHER SELECT™ Sirolimus-eluting Coronary Stent
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Device: Cypher Select
CYPHER SELECT™ Sirolimus-eluting Coronary Stent
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2: Active Comparator
CYPHER™ Sirolimus-eluting Coronary Stent
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Device: Cypher
CYPHER™ Sirolimus-eluting Coronary Stent
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This is a multicenter (up to 10 sites), open, prospective, 2-arm, unbalanced, randomized study designed to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent as compared to the CYPHER™ Sirolimus-eluting Coronary Stent. A total of 100 patients will be entered in the study and will be randomized on a 2:1 basis to the CYPHER SELECT™ stent or the CYPHER™ stent. 100 patients with de novo native coronary artery lesions <23 mm in length and more than 2.5 to less than 3.5 mm in diameter by visual estimate who meet all eligibility criteria will be either randomized.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Cardiothoracic Center Liverpool | |
Liverpool, United Kingdom, L14 3PE |
Principal Investigator: | R. H. Stables, MD | Cardiothoracic Centre Liverpool |
Responsible Party: | Cordis ( Dr. Hans-Peter Stoll, Director Clinical Affairs ) |
Study ID Numbers: | EC03-04 |
Study First Received: | October 4, 2005 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00232791 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Sirolimus Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |