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Sponsored by: |
Cordis Corporation |
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Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00235092 |
The main objective of this study is to compare the performance of the Cypher sirolimus-eluting and the Taxus paclitaxel-eluting stent systems in a prospective, multi-center, randomized clinical study.
Condition | Intervention | Phase |
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Coronary Artery Disease |
Device: Cypher Sirolimus-Eluting Stent Device: Taxus Paclitaxel-Eluting Stent |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Randomized, Multi-Center Comparison of the Cypher Sirolimus-Eluting and the Taxus Paclitaxel-Eluting Stent Systems. |
Estimated Enrollment: | 1335 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | March 2006 |
This is a prospective, randomized study conducted at 90 centers in Europe, Latin-America and Asia. A total of 1335 patients will be entered into the study and will be randomized on a 1:1 basis to either the sirolimus-eluting or the paclitaxel-eluting stent system. All patients will have repeat angiography at eight months and will be followed for 24 months post-procedure.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
8. Totally occluded vessel (TIMI 0 level) (applies to both lesions);
9. Prior stent within 10mm of target lesion (applies to both lesions).
Study ID Numbers: | EC03-02 |
Study First Received: | October 4, 2005 |
Last Updated: | April 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00235092 |
Health Authority: | France: Institutional Ethical Committee |
Arterial Occlusive Diseases Sirolimus Heart Diseases Clotrimazole Myocardial Ischemia Miconazole Vascular Diseases |
Tioconazole Ischemia Arteriosclerosis Coronary Disease Paclitaxel Coronary Artery Disease |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Therapeutic Uses Antifungal Agents Tubulin Modulators Cardiovascular Diseases Antineoplastic Agents, Phytogenic |