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Sponsors and Collaborators: |
Cordis Corporation Conor Medsystems |
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Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00606333 |
The purpose of this study is to evaluate the safety and effectiveness of the Conor Sirolimus-eluting Coronary Stent System in the treatment of coronary artery disease (a single atherosclerotic lesion) in native coronary arteries. The study will evaluate the outcomes of a new drug-eluting stent compared to an approved drug-eluting stent.
Condition | Intervention |
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Coronary Atherosclerosis |
Device: NEVO™ Sirolimus-eluting Coronary Stent System Device: Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Multi-Center, Single-Blind Comparison of the Conor Cobalt Chromium Reservoir Based Stent With Sirolimus Elution Versus the TAXUS Liberte Paclitaxel-eluting Coronary Stent System in De Novo Native Coronary Artery Lesions |
Enrollment: | 394 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | March 2013 |
Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Investigational arm: Experimental
Subjects randomized to treatment with the NEVO™ Sirolimus-eluting Coronary Stent System.
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Device: NEVO™ Sirolimus-eluting Coronary Stent System
Intervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques. Intervention in this arm will include treatment with the Conor Cobalt Chromium Sirolimus-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
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Control Arm: Active Comparator
Subjects randomized to treatment with the TAXUS Liberte Paclitaxel-eluting Coronary Stent System.
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Device: Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System)
Intervention will consist of percutaneous coronary intervention for treatment of a single coronary lesion using standard coronary intervention techniques. Intervention in this arm will include treatment with the TAXUS Liberte Paclitaxel-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
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Restenosis remains a frequent cause of late failure following successful coronary angioplasty occurring in an estimated 20-40% of procedures performed. Coronary stents provide mechanical scaffolding that helps reduce restenosis by limiting the extent of elastic recoil and late vascular remodeling. Despite improvements over balloon angioplasty alone, restenosis following coronary stenting procedures has been cited to occur in 20-40% of cases and is primarily a result of neointimal hyperplasia. Thus, stents which are capable of delivering drugs to limit neointimal hyperplasia, in addition to providing mechanical support at the area of the lesion, have been developed to further limit the extent of restenosis following coronary stenting. There are several pharmacologic agents approved for use with drug-eluting stents.Two drugs have been widely studied in controlled clinical trials and real-world patient populations, sirolimus and paclitaxel.
This study will evaluate a new sirolimus-eluting cobalt chromium coronary stent system compared to an approved paclitaxel-eluting coronary stent system in the treatment of single de novo coronary lesions in native coronary arteries. Subjects meeting qualification will be randomized in a 1:1 fashion to treatment with the Conor sirolimus-eluting coronary stent or to treatment with an approved paclitaxel-eluting coronary stent. All subjects will undergo angiographic follow-up at six months and complete clinical follow-up for a period of five years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil | |
Instituto Dante Pazzanese de Cardiologia | |
Sao Paulo, Brazil, 04012-909 | |
France | |
Cochin Hospital Rene Descartes University | |
Paris, France, 75014 | |
New Zealand, Auckland | |
Mercy Angiography Unit | |
Epsom, Auckland, New Zealand |
Principal Investigator: | Christian Spaulding | Cochin Hospital Rene Descartes University Paris FRANCE |
Principal Investigator: | John Ormiston, MB ChM | Mercy Angiography Unit |
Principal Investigator: | Alexandre Abizaid, MD. PhD | Instituto Dante Pazzanese de Cardiologia |
Responsible Party: | Cordis Corporation ( Sid Cohen, MD / Vice President Clinical Affairs ) |
Study ID Numbers: | CP-06 |
Study First Received: | January 17, 2008 |
Last Updated: | August 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00606333 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Federal Agency for Medicinal Products and Health Products; Brazil: National Committee of Ethics in Research; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Germany: German Institute of Medical Documentation and Information; Netherlands: Dutch Health Care Inspectorate; New Zealand: Institutional Review Board; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Coronary artery disease drug-eluting stents sirolimus-eluting coronary stents |
Atherosclerosis Arterial Occlusive Diseases Sirolimus Anti-Infective Agents Heart Diseases Immunologic Factors Chromium Myocardial Ischemia Vascular Diseases Antimitotic Agents Arteriosclerosis |
Ischemia Immunosuppressive Agents Coronary Disease Anti-Bacterial Agents Paclitaxel Antifungal Agents Cobalt Tubulin Modulators Antineoplastic Agents, Phytogenic Coronary Artery Disease |
Sirolimus Atherosclerosis Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myocardial Ischemia Physiological Effects of Drugs Arteriosclerosis Antibiotics, Antineoplastic Anti-Bacterial Agents Therapeutic Uses Antifungal Agents |
Cardiovascular Diseases Arterial Occlusive Diseases Heart Diseases Mitosis Modulators Vascular Diseases Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Coronary Disease Paclitaxel Tubulin Modulators Antineoplastic Agents, Phytogenic Coronary Artery Disease |