Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries (ZoMaxx™ II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00140101
First received: August 30, 2005
Last updated: January 6, 2012
Last verified: January 2012
  Purpose

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
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Device: ZoMaxx™ Drug-Eluting Coronary Stent System
Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • 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. [ Time Frame: at 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: at 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 1099
Study Start Date: May 2005
Study Completion Date: January 2012
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ZoMaxx™ Drug-Eluting Stent System
Device: ZoMaxx™ Drug-Eluting Coronary Stent System
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Active Comparator: 2
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System
Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria include all of the following:

  • 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

Exclusion Criteria include all of the following:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140101

  Hide Study Locations
Locations
United States, Alabama
Huntsville Hospital
Huntsville, Alabama, United States, 35801
United States, Arizona
ACS-Mesa General Hospital
Gilbert, Arizona, United States, 85233
United States, California
Scripps Memorial Hospital
La Jolla, California, United States, 92037
Foundation for Cardiovascular Medicine
La Jolla, California, United States, 92037
Sequoia Hospital
Redwood City, California, United States, 94062
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80262
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida Health Science Center
Gainesville, Florida, United States, 32610
Univ of Florida Health Science Center Shands
Jacksonville, Florida, United States, 32209
Florida Hospital
Orlando, Florida, United States, 32803
Morton Plant Hospital
Safety Harbor, Florida, United States, 34695
United States, Georgia
Emory Hospital
Atlanta, Georgia, United States, 30322
Piedmont Hospital
Atlanta, Georgia, United States, 30309
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
Emory Crawford Long Hospital
Atlanta, Georgia, United States, 30308
NE Georgia Medical Center
Gainesville, Georgia, United States, 30501
Medical Center of Central GA (MCCG)
Macon, Georgia, United States, 31201
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61614
St. John's Hospital and Memorial Medical Center
Springfield, Illinois, United States, 62701
United States, Indiana
The Heart Center of IN, LLC
Indianapolis, Indiana, United States, 46290
Clarion Health/Methodist Hospital
Indianapolis, Indiana, United States, 46202
United States, Iowa
Genesis Medical Center
Davenport, Iowa, United States, 52803
Iowa Heart Center/Methodist Hospital
Des Moines, Iowa, United States, 50309
University of Iowa Hospital
Iowa City, Iowa, United States, 52242-1081
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
St. Joseph Medical Center
Towson, Maryland, United States, 21204
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Cape Cod Research Institute
Hyannis, Massachusetts, United States, 02601
United States, Michigan
St. John's Hospital
Detroit, Michigan, United States, 48236
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, Mississippi
Baptist Hospital Desoto
Southaven, Mississippi, United States, 38761
United States, Missouri
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, New Jersey
Our Lady of Lourdes Medical Center
Cherry Hill, New Jersey, United States, 08103
United States, New York
St. Joseph's Hospital Health Center
Liverpool, New York, United States, 13088
Columbia Presbyterian Hospital
New York, New York, United States, 10032
Lenox Hill Hospital
New York, New York, United States, 10021
New York Presbyterian Hospital-Cornell
New York City, New York, United States, 10021
St. Francis Hospital
Roslyn, New York, United States, 11576
United States, North Carolina
Novant Medical Group
Charlotte, North Carolina, United States, 28204
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States, 27401
Wake Medical Hospital
Raleigh, North Carolina, United States, 27610
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Aultman Health Foundation
Canton, Ohio, United States, 44710
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
EMH Regional Medical Center
Elyria, Ohio, United States, 44035
United States, Oklahoma
Oklahoma Heart
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Pinnacle Health at Harrisburg Hospital
Harrisburg, Pennsylvania, United States, 17110
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Hahnemann University Hospital Drexel University
Philadelphia, Pennsylvania, United States, 19107
Univ of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, United States, 15213
Holy Spirit Hospital
Wormleysburg, Pennsylvania, United States, 17043
United States, South Carolina
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
United States, Tennessee
Erlanger Medical Center
Chattanooga, Tennessee, United States, 37403
United States, Texas
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
Lubbock Heart Hospital
Lubbock, Texas, United States, 79410
United States, Utah
Intermountain Medical Center
Salt Lake City, Utah, United States, 84103
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22031
United States, Washington
Overlake Hospital Medical Center
Bellevue, Washington, United States, 98004
North Cascade Cardiology / St. Joseph's Hospital
Bellingham, Washington, United States, 98225
Swedish Medical Center
Seattle, Washington, United States, 98104
Heart Clinics Northwest/ Sacred Heart Medical Center
Spokane, Washington, United States, 99204
Deaconess Medical Center
Spokane, Washington, United States, 99204
United States, Wisconsin
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Australia, New South Wales
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Eastern Heart Clinic, The Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Australia, Queensland
The Prince Charles Hospital
Chermside, Queensland, Australia, 4061
The Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4109
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Monash Medical Center - Cardiovascular Research Centre
Clayton, Victoria, Australia, 03168-
Australia
St. Vincent's Hospital
Fitzroy, Australia, 3065
Liverpool Hospital
New South Wales, Australia, 2170
Germany
RWTH Aachen
Aachen, Germany, 52074-
Charité - Campus Benjamin Franklin
Berlin, Germany
St.Johannes Krankenhaus
Dortmund, Germany, 44137
UKE Hamburg - Universitätsklinikum Eppendorf
Hamburg, Germany, 20251-
Uniklinik Homburg
Homburg, Germany, 66421
Leipzig Heart Center
Leipzig, Germany, 04289
Uniklinik Mainz - Johannes Gutenberg Universitat
Mainz, Germany, 55131-
Krankenhaus Siegburg - Heart Center Siegburg
Siegburg, Germany, 53721
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1003
Christchurch Hospital
Christchurch, New Zealand
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Alan Yeung, M.D. Stanford University
Study Director: David Lee, M.D. Stanford University
  More Information

No publications provided by Abbott Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00140101     History of Changes
Other Study ID Numbers: 640-0048, 96039
Study First Received: August 30, 2005
Last Updated: January 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Vascular:
drug eluting stents
stents
angioplasty
coronary artery disease
total coronary occlusion
coronary artery restenosis
stent thrombosis
vascular disease
myocardial ischemia
coronary artery stenosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Stenosis
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014