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Sponsored by: |
Abbott Vascular |
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Information provided by: | Abbott Vascular |
ClinicalTrials.gov Identifier: | NCT00148356 |
The purpose of this study is to demonstrate the safety and efficacy of the ZoMaxx drug-eluting stent in patients with blockage of native coronary arteries. The study is designed to demonstrate non-inferiority to the TAXUS Express2 Paclitaxel-Eluting Stent that has proven superior to bare metal stents and is a recognized standard of care.
Condition | Intervention | Phase |
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Coronary Disease Coronary Artery Disease Coronary Restenosis |
Device: ZoMaxx™ Drug-Eluting Coronary Stent System Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the ZoMaxx Drug Eluting Coronary Stent System Compared to the TAXUS™ Express2 Paclitaxel-Eluting Coronary Stent System in de Novo Coronary Artery Lesions |
Enrollment: | 401 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | July 2010 |
Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
ZoMaxx™ Drug-Eluting Stent System
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Device: ZoMaxx™ Drug-Eluting Coronary Stent System
Drug eluting stent implantation stent in the treatment of coronary artery disease.
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2: Active Comparator
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System
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Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System
Drug eluting stent implantation stent in the treatment of coronary artery disease.
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Heart disease is the leading cause of death in Europe as a whole, and while mortality rates for cardiovascular disease have decreased in most western European countries, due to expanded use of prevention strategies and better treatment, coronary heart disease mortality in the middle age groups is increasing rapidly in most of the countries in Eastern Europe. The number of procedures performed to treat cardiovascular disease in Europe is constantly increasing, although different types of procedures are exhibiting different trends. Percutaneous coronary interventions (PCI) procedures, for example, totaled 430,000 in the European Union (15 countries) and 520,000 in Europe as a whole (33 countries) in 2000, as reported by the Euro Heart Survey, and growth is continuing at a rate of more than 20% per year. Despite the effectiveness of intracoronary stents in maintaining a larger luminal diameter as compared to angioplasty alone, 15 - 35% of in-stent restenosis occurs within 6 to 9 months after stent placement. While stents can reduce restenosis by blocking vascular recoil and remodeling, mechanical intervention alone is incapable of treating the biological problem of neointimal hyperplasia. Various approaches have been used to treat in-stent restenosis, including balloon angioplasty, repeat stenting, rotational and directional atherectomy, laser and local use of radiation at the time of stenting (brachytherapy). However, these techniques add complexity to the interventional procedure and have not had documented success in preventing restenosis. Drug-eluting stents (DES) using antiproliferative agents delivered via a polymer based stent platform have shown significant success in the reduction of restenosis in de novo lesions over the traditional bare metal stents in randomized clinical trials. Local delivery of the pharmacological agent allows for controlled delivery of high drug concentrations to the targeted tissue while maximizing systemic drug effects. The ZoMaxx I Trial is a study of the ZoMaxx Drug Eluting Coronary Stent System (ZoMaxx DES) to evaluate the potential benefits of the local application of the zotarolimus drug in combination with a phosphorylcholine (PC)-coated tri-metal stent.
ZoMaxx™ Drug-Eluting Stent System is an Investigational device. Limited by Federal (U.S.) law to investigational use only.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria include all of the following:
Exclusion Criteria include all of the following:
France | |
Centre Cardilogique du Nord, 32-36, rue des Moulins Gémeaux | |
Saint-Denis, France, 93200 |
Principal Investigator: | Bernard Chevalier, M.D. | Centre Cardiologique du Nord |
Responsible Party: | Abbott Vascular ( Abbott Vascular ) |
Study ID Numbers: | 640-0047 |
Study First Received: | September 6, 2005 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00148356 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
drug eluting stents stents angioplasty coronary artery disease total coronary occlusion |
coronary artery restenosis stent thrombosis vascular disease myocardial ischemia coronary artery stenosis |
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Vascular Diseases Constriction, Pathologic Ischemia Arteriosclerosis |
Coronary Restenosis Coronary Stenosis Thrombosis Coronary Disease Coronary Occlusion Paclitaxel Coronary Artery Disease |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Mitosis Modulators Tubulin Modulators |
Cardiovascular Diseases Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |