Coronary Artery Disease Clinical Trial
— ZoMaxx™ IOfficial 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
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.
Status | Completed |
Enrollment | 401 |
Est. completion date | October 2010 |
Est. primary completion date | May 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria include all of the following: - Subject is = 18 years old. - Female of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment and utilize reliable birth control for nine (9) months after enrollment. - Subject is eligible for percutaneous coronary intervention (PCI) and has a single lesion requiring treatment. - Subject is an acceptable candidate for CABG. - Subject has clinical evidence of ischemic heart disease or a positive functional study. - Subject has documented stable angina pectoris Exclusion Criteria include all of the following: - Evidence of an acute myocardial infarction (AMI) or CK-MB > 2x upper limit of normal within 72 hours of the intended treatment (refer to WHO definition). - Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, stainless steel, tantalum, contrast agent (that cannot be adequately premedicated), paclitaxel, or drugs similar to ABT-578 (i.e. tacrolimus, sirolimus, everolimus). - A platelet count < 100 x 109/L or > 700 x 109/L (< 100,000 cells/mm3 or > 700,000 cells/mm3); a WBC < 3,000 cells/mm3; or a hemoglobin < 10.0 g/dl. - Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or > 150 µmol/L). - Subject has had any previous or planned brachytherapy in the target vessel. - Target vessel has evidence of thrombus or is excessively tortuous (> 60 degree bend) that makes it unsuitable for proper stent delivery and deployment. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | St. Vincent's Hospital | Fitzroy | Victoria |
Australia | Monash Medical Center | Victoria | |
Belgium | Onze Lieve Vrouw Hospital | Aalst | |
Belgium | Middelheim Algemeen Ziekenhuis | Antwerpen | |
Belgium | KU Leuven - UZ Gasthuisberg | Leuven | |
Belgium | C.H.U. Sart Tilman | Liège | |
Denmark | Skejby Sygehus | Århus | |
Denmark | Rigshospitalet / University of Copenhagen | Copenhagen | |
France | Polyclinique les Fleurs | Ollioules | |
France | Centre Cardilogique du Nord, 32-36, rue des Moulins Gémeaux | Saint-Denis | |
France | Clinique Pasteur | Toulouse | |
France | Hôpital de Rangueil - CHU | Toulouse, Cedex 9 | |
France | Clinique Saint Gatien | Tours | |
Germany | Herzzentrum Bad Krozingen | Bad Krozingen | |
Germany | St.Johannes Krankenhaus | Dortmund | |
Germany | Universitätsklinikum Essen | Essen | |
Germany | Universitätsklinikum Eppendorf | Hamburg | |
Germany | Herzzentrum Leipzig | Leipzig | |
Germany | Cardiology Practice and Hospital Prof. Silber | Munich | |
Germany | Herzzentrum Siegburg GmbH | Siegburg | |
Netherlands | Erasmus Medical Center | Rotterdam | |
New Zealand | Auckland City Hospital | Auckland | |
New Zealand | Dunedin Hospital | Dunedin | |
Portugal | Hospital de Santa Cruz | Carnaxide | |
Switzerland | Herzzentrum Bodensee | Kreuzlingen | |
Switzerland | La Tour Hospital | Meyrin-Geneva | |
Switzerland | University Hospital Zürich | Zürich | |
United Kingdom | Barts and the London NHS Trust | London | |
United Kingdom | Royal Brompton Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Abbott Vascular |
Australia, Belgium, Denmark, France, Germany, Netherlands, New Zealand, Portugal, Switzerland, United Kingdom,
Chevalier B, Di Mario C, Neumann FJ, Ribichini F, Urban P, Popma JJ, Fitzgerald PJ, Cutlip DE, Williams DO, Ormiston J, Grube E, Whitbourn R, Schwartz LB; ZoMaxx I Investigators. A randomized, controlled, multicenter trial to evaluate the safety and effic — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary end-point is in-segment late-loss at 9 months (as measured by QCA), defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD. | 9 months | Yes | |
Secondary | Target Lesion revascularization(TLR) | at 9 months | Yes | |
Secondary | Target Vessel Revascularization (TVR) | at 9 months | Yes | |
Secondary | Target Vessel Failure | at 9 months | Yes | |
Secondary | Major Adverse Cardiac Events(MACE) defined as Cardiac Death, MI( Q-wave and non Q-wave) or TVR | at 30 days, 6,9,12 months and anually through 5 years | Yes |
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