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Sponsored by: |
Cordis Corporation |
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Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00232856 |
The main objective of this study is to assess the safety and effectiveness of the Cypher™ sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an in-stent restenotic native coronary artery lesion.
Condition | Intervention | Phase |
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Coronary Artery Disease |
Device: drug-eluting stent |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Non-Randomised Study of the CYPHER™ Sirolimus-Eluting Stent in the Treatment of Patient With an in-Stent Restenotic Native Coronary Artery Lesion |
Enrollment: | 162 |
Study Start Date: | December 2002 |
Study Completion Date: | August 2006 |
Primary Completion Date: | December 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Cypher™ sirolimus-eluting stent
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Device: drug-eluting stent
PCI
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This is a multicenter (11 sites), non-randomized study. Patients who meet the eligibility criteria will be treated with the Cypher™ sirolimus-eluting stent. All patients will have a repeat angiography at six months post-procedure and will be additionally followed clinically at 1, 6 and 9 months and up to 3 years. The results of this study will be compared with the outcome of the GAMMA I / II as the historical control.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
K.U. Leuven | |
Leuven, Belgium, 3000 | |
Germany | |
Herz-zentrum Bad Krozingen | |
Bad-Krozingen, Germany, 78189 |
Principal Investigator: | Franz-Josef Neumann, MD | Herz-zentrum Bad Krozingen |
Principal Investigator: | Walter Desmet, MD | K.U. Leuven |
Responsible Party: | Cordis ( Hans-Peter Stoll - Director Medical Affairs ) |
Study ID Numbers: | EC01-06 |
Study First Received: | October 4, 2005 |
Last Updated: | April 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00232856 History of Changes |
Health Authority: | Belgium: Institutional Review Board; Netherlands: Independent Ethics Committee; Germany: Ethics Commission; Italy: Ethics Committee |
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 |