Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
ZoMaxx™ II
A Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the ZoMaxx Drug Eluting Coronary Stent System as Compared to the TAXUS™ Express2™ Paclitaxel-Eluting Stent in de Novo Coronary Artery Lesions
2 other identifiers
interventional
1,099
4 countries
92
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2005
Longer than P75 for phase_2
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJanuary 10, 2012
January 1, 2012
2.3 years
August 30, 2005
January 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
1
EXPERIMENTALZoMaxx™ Drug-Eluting Stent System
2
ACTIVE COMPARATORTAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System
Interventions
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Eligibility Criteria
You may qualify if:
- Subject is ≥ 18 years old
- Subject is eligible for percutaneous coronary intervention (PCI) and has a single lesion requiring treatment
- Subject is an acceptable candidate for CABG
- Clinical evidence of ischemic heart disease or a positive functional study
- Documented stable angina pectoris
- The target lesion is a single de novo coronary artery lesion with ≥50 and \<100% stenosis by visual estimate
You may not qualify if:
- Female of childbearing potential. Female subjects must be medically or surgically sterile or diagnosed as post-menopausal (i.e. one year since final menstrual cycle.
- Evidence of an acute myocardial infarction and/or CK-MB\>2x upper limit of normal within 72 hours of the intended treatment
- Known allergies to the following: aspirin, clopidogrel (Plavix) or ticlopidine (Ticlid), heparin, stainless steel, tantalum, contrast agent (that cannot be adequately premedicated), paclitaxel or drugs similar to zotarolimus (ABT-578) (i.e. tacrolimus, sirolimus, everolimus)
- A platelet count \<100,000 cells/mm3or \>700,000 cells/mm3; a WBC \<3,000 cells/mm3; or hemoglobin \<10.0g/dL
- Acute or chronic renal dysfunction (creatinine \>2.0 mg/dl or \>150µmol/L)
- Subject has had any previous or planned brachytherapy in the target vessel
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (92)
Huntsville Hospital
Huntsville, Alabama, 35801, United States
ACS-Mesa General Hospital
Gilbert, Arizona, 85233, United States
Foundation for Cardiovascular Medicine
La Jolla, California, 92037, United States
Scripps Memorial Hospital
La Jolla, California, 92037, United States
Sequoia Hospital
Redwood City, California, 94062, United States
Stanford University Medical Center
Stanford, California, 94305, United States
University of Colorado
Denver, Colorado, 80262, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Florida Health Science Center
Gainesville, Florida, 32610, United States
Univ of Florida Health Science Center Shands
Jacksonville, Florida, 32209, United States
Florida Hospital
Orlando, Florida, 32803, United States
Morton Plant Hospital
Safety Harbor, Florida, 34695, United States
Emory Crawford Long Hospital
Atlanta, Georgia, 30308, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Emory Hospital
Atlanta, Georgia, 30322, United States
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342, United States
NE Georgia Medical Center
Gainesville, Georgia, 30501, United States
Medical Center of Central GA (MCCG)
Macon, Georgia, 31201, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61614, United States
St. John's Hospital and Memorial Medical Center
Springfield, Illinois, 62701, United States
Clarion Health/Methodist Hospital
Indianapolis, Indiana, 46202, United States
The Heart Center of IN, LLC
Indianapolis, Indiana, 46290, United States
Genesis Medical Center
Davenport, Iowa, 52803, United States
Iowa Heart Center/Methodist Hospital
Des Moines, Iowa, 50309, United States
University of Iowa Hospital
Iowa City, Iowa, 52242-1081, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
St. Joseph Medical Center
Towson, Maryland, 21204, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Cape Cod Research Institute
Hyannis, Massachusetts, 02601, United States
St. John's Hospital
Detroit, Michigan, 48236, United States
Northern Michigan Hospital
Petoskey, Michigan, 49770, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Baptist Hospital Desoto
Southaven, Mississippi, 38761, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Our Lady of Lourdes Medical Center
Cherry Hill, New Jersey, 08103, United States
St. Joseph's Hospital Health Center
Liverpool, New York, 13088, United States
Lenox Hill Hospital
New York, New York, 10021, United States
New York Presbyterian Hospital-Cornell
New York, New York, 10021, United States
Columbia Presbyterian Hospital
New York, New York, 10032, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Novant Medical Group
Charlotte, North Carolina, 28204, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401, United States
Wake Medical Hospital
Raleigh, North Carolina, 27610, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
EMH Regional Medical Center
Elyria, Ohio, 44035, United States
Oklahoma Heart
Oklahoma City, Oklahoma, 73120, United States
Pinnacle Health at Harrisburg Hospital
Harrisburg, Pennsylvania, 17110, United States
Hahnemann University Hospital Drexel University
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Univ of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, 15213, United States
Holy Spirit Hospital
Wormleysburg, Pennsylvania, 17043, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
Lubbock Heart Hospital
Lubbock, Texas, 79410, United States
Intermountain Medical Center
Salt Lake City, Utah, 84103, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22031, United States
Overlake Hospital Medical Center
Bellevue, Washington, 98004, United States
North Cascade Cardiology / St. Joseph's Hospital
Bellingham, Washington, 98225, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Deaconess Medical Center
Spokane, Washington, 99204, United States
Heart Clinics Northwest/ Sacred Heart Medical Center
Spokane, Washington, 99204, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
Eastern Heart Clinic, The Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
The Prince Charles Hospital
Chermside, Queensland, 4061, Australia
The Princess Alexandra Hospital
Woolloongabba, Queensland, 4109, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Monash Medical Center - Cardiovascular Research Centre
Clayton, Victoria, 03168-, Australia
St. Vincent's Hospital
Fitzroy, 3065, Australia
Liverpool Hospital
New South Wales, 2170, Australia
RWTH Aachen
Aachen, 52074-, Germany
Charité - Campus Benjamin Franklin
Berlin, Germany
St.Johannes Krankenhaus
Dortmund, 44137, Germany
UKE Hamburg - Universitätsklinikum Eppendorf
Hamburg, 20251-, Germany
Uniklinik Homburg
Homburg, 66421, Germany
Leipzig Heart Center
Leipzig, 04289, Germany
Uniklinik Mainz - Johannes Gutenberg Universitat
Mainz, 55131-, Germany
Krankenhaus Siegburg - Heart Center Siegburg
Siegburg, 53721, Germany
Auckland City Hospital
Auckland, 1003, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Related Publications (1)
Gray WA, Yeung AC, Cutlip DE, Popma JJ, Fitzgerald PJ, Williams DO, Heuer H, O'Shaughnessy CD, Overlie PA, Mann JT, Cannon LA, Hermiller JB, Henry TD, Whitbourn R, Stuckey TD, Midei MG, Coe J, Schwartz LB. A randomized, controlled, multi-center trial comparing the safety and efficacy of zotarolimus-eluting and paclitaxel-eluting stents in de novo lesions in coronary arteries: final results of the ZoMaxx II trial. Int J Cardiol. 2012 May 17;157(1):96-101. doi: 10.1016/j.ijcard.2011.05.061. Epub 2011 Jun 11.
PMID: 21658783DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Yeung, M.D.
Stanford University
- STUDY DIRECTOR
David Lee, M.D.
Stanford University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2005
First Posted
September 1, 2005
Study Start
May 1, 2005
Primary Completion
September 1, 2007
Study Completion
January 1, 2012
Last Updated
January 10, 2012
Record last verified: 2012-01