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Sponsored by: |
Deutsches Herzzentrum Muenchen |
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Information provided by: | Deutsches Herzzentrum Muenchen |
ClinicalTrials.gov Identifier: | NCT00598533 |
The purpose of this trial is to evaluate the efficacy of Rapamycin- and Zotarolimus-Eluting stents for the reduction of Coronary Restenosis
Condition | Intervention | Phase |
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Coronary Heart Disease |
Device: Rapamycin + Probucol-eluting stent (ISAR stent) Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prospective, Randomized Trial of Rapamycin- and Zotarolimus-Eluting Stents for the Reduction of Coronary Restenosis |
Estimated Enrollment: | 3000 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Rapamycin + Probucol-eluting stent
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Device: Rapamycin + Probucol-eluting stent (ISAR stent)
due to randomization, Rapamycin- + Probucol-eluting stent will be implanted
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2: Active Comparator
Polymer based Zotarolimus-eluting stent
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Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute)
due to randomization, Zotarolimus-eluting stent with polymer will be implanted
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This prospective, randomized trial will compare the efficacy and safety of a Rapamycin plus Probucol-eluting stent with a polymer based Zotarolimus-eluting stent. Patients with symptomatic coronary artery disease without cardiogenic shock who will undergo coronary angiography and willing to participate in the trial will receive a loading dose of 600mg clopidogrel at least 2 hours before the procedure. They will be randomized to receive one of the above mentioned stents.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Adnan Kastrati, MD | +49 89 12 18-0 ext 4577 | kastrati@dhm.mhn.de |
Contact: Julinda Mehilli, MD | +49 89 12 18-0 ext 4582 | mehilli@dhm.mhn.de |
Germany | |
Deutsches Herzzentrum Muenchen | Recruiting |
Munich, Germany, 80636 | |
Contact: Adnan Kastrati, MD +49 89 1218-0 ext 4577 kastrati@dhm.mhn.de | |
Principal Investigator: Julinda Mehilli, MD | |
Medizinische Klinik, Klinikum rechts der Isar | Recruiting |
Muenchen, Germany, 81675 | |
Contact: Josef Dirschinger, MD +49 89 4140 2947 | |
Principal Investigator: Josef Dirschinger, MD |
Study Chair: | Albert Schoemig, MD | Deutsches Herzzentrum Muenchen |
Responsible Party: | Deutsches Herzzentrum Munich ( Prof. A. Schömig ) |
Study ID Numbers: | GE IDE No. S02907 |
Study First Received: | January 10, 2008 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00598533 History of Changes |
Health Authority: | Germany: German Institute of Medical Documentation and Information |
Antimetabolites Arterial Occlusive Diseases Sirolimus Anti-Infective Agents Antioxidants Heart Diseases Probucol Immunologic Factors Antilipemic Agents Myocardial Ischemia Vascular Diseases |
Constriction, Pathologic Anticholesteremic Agents Ischemia Arteriosclerosis Immunosuppressive Agents Coronary Restenosis Coronary Stenosis Coronary Disease Anti-Bacterial Agents Antifungal Agents Coronary Artery Disease |
Sirolimus Antimetabolites Anti-Infective Agents Antioxidants 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 Probucol Heart Diseases Antilipemic Agents Vascular Diseases Anticholesteremic Agents Immunosuppressive Agents Coronary Stenosis Coronary Restenosis Protective Agents Pharmacologic Actions Coronary Disease Coronary Artery Disease |