Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
- Conditions
- Coronary DiseaseCoronary Artery DiseaseCoronary Restenosis
- Interventions
- Device: ZoMaxx™ Drug-Eluting Coronary Stent SystemDevice: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Registration Number
- NCT00140101
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
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.
- Detailed Description
Coronary artery disease is the major cause of morbidity and mortality in the United States. The American Heart Association estimates that 571,000 Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures were performed in 2001 in the United States and that 80% to 90% of these patients also underwent stent placement. Despite the effectiveness of intracoronary stents in maintaining a larger luminal diameter as compared to angioplasty alone, 15 to 35% 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 delivery 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 in-stent 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 minimizing systemic drug effects. The ZoMaxx II Trial represents the first US study of the ZoMaxx(TM) Drug Eluting Coronary Stent System 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1099
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 ZoMaxx™ Drug-Eluting Coronary Stent System ZoMaxx™ Drug-Eluting Stent System 2 TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System
- Primary Outcome Measures
Name Time Method The primary endpoint is TVR (Target Vessel Revascularization). TVR is defined as any ischemia driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. at 9 months
- Secondary Outcome Measures
Name Time Method The major secondary endpoint is in-segment late loss as measured by QCA. In-segment late loss is defined as the difference between the post-procedure minimal luminal diameter (MLD) and the follow-up angiography MLD. at 9 months
Trial Locations
- Locations (92)
Wake Medical Hospital
🇺🇸Raleigh, North Carolina, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
ACS-Mesa General Hospital
🇺🇸Gilbert, Arizona, United States
Sequoia Hospital
🇺🇸Redwood City, California, United States
Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
University of Florida Health Science Center
🇺🇸Gainesville, Florida, United States
Huntsville Hospital
🇺🇸Huntsville, Alabama, United States
Medical Center of Central GA (MCCG)
🇺🇸Macon, Georgia, United States
Emory Hospital
🇺🇸Atlanta, Georgia, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
University of Iowa Hospital
🇺🇸Iowa City, Iowa, United States
Univ of Florida Health Science Center Shands
🇺🇸Jacksonville, Florida, United States
Iowa Heart Center/Methodist Hospital
🇺🇸Des Moines, Iowa, United States
Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Foundation for Cardiovascular Medicine
🇺🇸La Jolla, California, United States
Univ of Pittsburgh Medical Center Health System
🇺🇸Pittsburgh, Pennsylvania, United States
EMH Regional Medical Center
🇺🇸Elyria, Ohio, United States
Eastern Heart Clinic, The Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Columbia Presbyterian Hospital
🇺🇸New York, New York, United States
NE Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Emory Crawford Long Hospital
🇺🇸Atlanta, Georgia, United States
St. Joseph's Hospital of Atlanta
🇺🇸Atlanta, Georgia, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
St. Joseph's Hospital Health Center
🇺🇸Liverpool, New York, United States
Pinnacle Health at Harrisburg Hospital
🇺🇸Harrisburg, Pennsylvania, United States
Morton Plant Hospital
🇺🇸Safety Harbor, Florida, United States
Barnes Jewish Hospital
🇺🇸St. Louis, Missouri, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Overlake Hospital Medical Center
🇺🇸Bellevue, Washington, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Medical University of South Carolina (MUSC)
🇺🇸Charleston, South Carolina, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
St. John's Hospital and Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
St. Joseph Medical Center
🇺🇸Towson, Maryland, United States
Heart Clinics Northwest/ Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
St. Vincent's Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
St.Johannes Krankenhaus
🇩🇪Dortmund, Germany
Charité - Campus Benjamin Franklin
🇩🇪Berlin, Germany
St. Vincent's Hospital
🇦🇺Fitzroy, Australia
Leipzig Heart Center
🇩🇪Leipzig, Germany
UKE Hamburg - Universitätsklinikum Eppendorf
🇩🇪Hamburg, Germany
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Lubbock Heart Hospital
🇺🇸Lubbock, Texas, United States
North Cascade Cardiology / St. Joseph's Hospital
🇺🇸Bellingham, Washington, United States
Liverpool Hospital
🇦🇺New South Wales, Australia
RWTH Aachen
🇩🇪Aachen, Germany
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
The Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Deaconess Medical Center
🇺🇸Spokane, Washington, United States
Monash Medical Center - Cardiovascular Research Centre
🇦🇺Clayton, Victoria, Australia
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Auckland City Hospital
🇳🇿Auckland, New Zealand
Uniklinik Mainz - Johannes Gutenberg Universitat
🇩🇪Mainz, Germany
Clarion Health/Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
The Heart Center of IN, LLC
🇺🇸Indianapolis, Indiana, United States
St. Luke's Episcopal Hospital
🇺🇸Houston, Texas, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
St. John's Hospital
🇺🇸Detroit, Michigan, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Oklahoma Heart
🇺🇸Oklahoma City, Oklahoma, United States
Intermountain Medical Center
🇺🇸Salt Lake City, Utah, United States
Uniklinik Homburg
🇩🇪Homburg, Germany
Krankenhaus Siegburg - Heart Center Siegburg
🇩🇪Siegburg, Germany
University of Colorado
🇺🇸Denver, Colorado, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Cape Cod Research Institute
🇺🇸Hyannis, Massachusetts, United States
Holy Spirit Hospital
🇺🇸Wormleysburg, Pennsylvania, United States
Novant Medical Group
🇺🇸Charlotte, North Carolina, United States
New York Presbyterian Hospital-Cornell
🇺🇸New York City, New York, United States
Moses H. Cone Memorial Hospital
🇺🇸Greensboro, North Carolina, United States
Northern Michigan Hospital
🇺🇸Petoskey, Michigan, United States
Baptist Hospital Desoto
🇺🇸Southaven, Mississippi, United States
Our Lady of Lourdes Medical Center
🇺🇸Cherry Hill, New Jersey, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Aultman Health Foundation
🇺🇸Canton, Ohio, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Hahnemann University Hospital Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
Erlanger Medical Center
🇺🇸Chattanooga, Tennessee, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States