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

NCT ID: NCT00140101

Last Updated: 2012-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1099 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2012-01-31

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.

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

ZoMaxx™ Drug-Eluting Stent System

Group Type: EXPERIMENTAL

ZoMaxx™ Drug-Eluting Coronary Stent System

Intervention Type: DEVICE

Drug eluting stent implantation stent in the treatment of coronary artery disease.

2

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System

Group Type: ACTIVE_COMPARATOR

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

Intervention Type: DEVICE

Drug eluting stent implantation stent in the treatment of coronary artery disease.

Interventions

ZoMaxx™ Drug-Eluting Coronary Stent System

Drug eluting stent implantation stent in the treatment of coronary artery disease.

Intervention Type: DEVICE

TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

Drug eluting stent implantation stent in the treatment of coronary artery disease.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan Yeung, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

David Lee, M.D.

Role: STUDY_DIRECTOR

Stanford University

Locations

Huntsville Hospital

Huntsville, Alabama, United States

ACS-Mesa General Hospital

Gilbert, Arizona, United States

Foundation for Cardiovascular Medicine

La Jolla, California, United States

Scripps Memorial Hospital

La Jolla, California, United States

Sequoia Hospital

Redwood City, California, United States

Stanford University Medical Center

Stanford, California, United States

University of Colorado

Denver, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

University of Florida Health Science Center

Gainesville, Florida, United States

Univ of Florida Health Science Center Shands

Jacksonville, Florida, United States

Florida Hospital

Orlando, Florida, United States

Morton Plant Hospital

Safety Harbor, Florida, United States

Emory Crawford Long Hospital

Atlanta, Georgia, United States

Piedmont Hospital

Atlanta, Georgia, United States

Emory Hospital

Atlanta, Georgia, United States

St. Joseph's Hospital of Atlanta

Atlanta, Georgia, United States

NE Georgia Medical Center

Gainesville, Georgia, United States

Medical Center of Central GA (MCCG)

Macon, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

OSF St. Francis Medical Center

Peoria, Illinois, United States

St. John's Hospital and Memorial Medical Center

Springfield, Illinois, United States

Clarion Health/Methodist Hospital

Indianapolis, Indiana, United States

The Heart Center of IN, LLC

Indianapolis, Indiana, United States

Genesis Medical Center

Davenport, Iowa, United States

Iowa Heart Center/Methodist Hospital

Des Moines, Iowa, United States

University of Iowa Hospital

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Central Baptist Hospital

Lexington, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

St. Joseph Medical Center

Towson, Maryland, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Cape Cod Research Institute

Hyannis, Massachusetts, United States

St. John's Hospital

Detroit, Michigan, United States

Northern Michigan Hospital

Petoskey, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Baptist Hospital Desoto

Southaven, Mississippi, United States

Barnes Jewish Hospital

St Louis, Missouri, United States

Our Lady of Lourdes Medical Center

Cherry Hill, New Jersey, United States

St. Joseph's Hospital Health Center

Liverpool, New York, United States

Lenox Hill Hospital

New York, New York, United States

New York Presbyterian Hospital-Cornell

New York, New York, United States

Columbia Presbyterian Hospital

New York, New York, United States

St. Francis Hospital

Roslyn, New York, United States

Novant Medical Group

Charlotte, North Carolina, United States

Moses H. Cone Memorial Hospital

Greensboro, North Carolina, United States

Wake Medical Hospital

Raleigh, North Carolina, United States

Forsyth Medical Center

Winston-Salem, North Carolina, United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Aultman Health Foundation

Canton, Ohio, United States

The Christ Hospital

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

EMH Regional Medical Center

Elyria, Ohio, United States

Oklahoma Heart

Oklahoma City, Oklahoma, United States

Pinnacle Health at Harrisburg Hospital

Harrisburg, Pennsylvania, United States

Hahnemann University Hospital Drexel University

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Univ of Pittsburgh Medical Center Health System

Pittsburgh, Pennsylvania, United States

Holy Spirit Hospital

Wormleysburg, Pennsylvania, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Erlanger Medical Center

Chattanooga, Tennessee, United States

St. Luke's Episcopal Hospital

Houston, Texas, United States

Lubbock Heart Hospital

Lubbock, Texas, United States

Intermountain Medical Center

Salt Lake City, Utah, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Overlake Hospital Medical Center

Bellevue, Washington, United States

North Cascade Cardiology / St. Joseph's Hospital

Bellingham, Washington, United States

Swedish Medical Center

Seattle, Washington, United States

Deaconess Medical Center

Spokane, Washington, United States

Heart Clinics Northwest/ Sacred Heart Medical Center

Spokane, Washington, United States

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

St. Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Eastern Heart Clinic, The Prince of Wales Hospital

Randwick, New South Wales, Australia

The Prince Charles Hospital

Chermside, Queensland, Australia

The Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Monash Medical Center - Cardiovascular Research Centre

Clayton, Victoria, Australia

St. Vincent's Hospital

Fitzroy, , Australia

Liverpool Hospital

New South Wales, , Australia

RWTH Aachen

Aachen, , Germany

Charité - Campus Benjamin Franklin

Berlin, , Germany

St.Johannes Krankenhaus

Dortmund, , Germany

UKE Hamburg - Universitätsklinikum Eppendorf

Hamburg, , Germany

Uniklinik Homburg

Homburg, , Germany

Leipzig Heart Center

Leipzig, , Germany

Uniklinik Mainz - Johannes Gutenberg Universitat

Mainz, , Germany

Krankenhaus Siegburg - Heart Center Siegburg

Siegburg, , Germany

Auckland City Hospital

Auckland, , New Zealand

Christchurch Hospital

Christchurch, , New Zealand

Countries

United States; Australia; Germany; New Zealand

References

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.

Reference Type: DERIVED

PMID: 21658783 (View on PubMed)

Other Identifiers

96039

Identifier Type: -

Identifier Source: secondary_id

640-0048

Identifier Type: -

Identifier Source: org_study_id