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

January 6, 2012 updated by: Abbott Medical Devices

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1099

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Alan Yeung, M.D., Stanford University
  • Study Director: David Lee, M.D., Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

September 1, 2005

Study Record Updates

Last Update Posted (Estimate)

January 10, 2012

Last Update Submitted That Met QC Criteria

January 6, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 640-0048
  • 96039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe