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Coronary DiseasePhase 2ZoMaxx™ IINCT00140101

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

A Phase 2 study testing ZoMaxx™ Drug-Eluting Coronary Stent System and TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent in people with Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 92 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ZoMaxx™ Drug-Eluting Coronary Stent System and TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,099 participants
Where
92 sitesin 4 countries
Study dates
May 2005to Jan 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

92 sites in 4 countries.

92 sites in 4 countries

United States74 sites

  • Emory Crawford Long Hospital

    Atlanta, Georgia, 30308

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory Hospital

    Atlanta, Georgia, 30322

  • St. Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342

  • Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • North Cascade Cardiology / St. Joseph's Hospital

    Bellingham, Washington, 98225

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • Novant Medical Group

    Charlotte, North Carolina, 28204

  • Erlanger Medical Center

    Chattanooga, Tennessee, 37403

  • Our Lady of Lourdes Medical Center

    Cherry Hill, New Jersey, 08103

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Genesis Medical Center

    Davenport, Iowa, 52803

  • University of Colorado

    Denver, Colorado, 80262

  • Iowa Heart Center/Methodist Hospital

    Des Moines, Iowa, 50309

  • St. John's Hospital

    Detroit, Michigan, 48236

  • EMH Regional Medical Center

    Elyria, Ohio, 44035

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22031

  • University of Florida Health Science Center

    Gainesville, Florida, 32610

  • NE Georgia Medical Center

    Gainesville, Georgia, 30501

  • ACS-Mesa General Hospital

    Gilbert, Arizona, 85233

  • Moses H. Cone Memorial Hospital

    Greensboro, North Carolina, 27401

  • Pinnacle Health at Harrisburg Hospital

    Harrisburg, Pennsylvania, 17110

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • Huntsville Hospital

    Huntsville, Alabama, 35801

  • Cape Cod Research Institute

    Hyannis, Massachusetts, 02601

  • Clarion Health/Methodist Hospital

    Indianapolis, Indiana, 46202

  • The Heart Center of IN, LLC

    Indianapolis, Indiana, 46290

  • University of Iowa Hospital

    Iowa City, Iowa, 52242-1081

  • Univ of Florida Health Science Center Shands

    Jacksonville, Florida, 32209

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Foundation for Cardiovascular Medicine

    La Jolla, California, 92037

  • Scripps Memorial Hospital

    La Jolla, California, 92037

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • St. Joseph's Hospital Health Center

    Liverpool, New York, 13088

  • Lubbock Heart Hospital

    Lubbock, Texas, 79410

  • Medical Center of Central GA (MCCG)

    Macon, Georgia, 31201

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Lenox Hill Hospital

    New York, New York, 10021

  • New York Presbyterian Hospital-Cornell

    New York, New York, 10021

  • Columbia Presbyterian Hospital

    New York, New York, 10032

  • Oklahoma Heart

    Oklahoma City, Oklahoma, 73120

  • Florida Hospital

    Orlando, Florida, 32803

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61614

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Hahnemann University Hospital Drexel University

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Univ of Pittsburgh Medical Center Health System

    Pittsburgh, Pennsylvania, 15213

  • Wake Medical Hospital

    Raleigh, North Carolina, 27610

  • Sequoia Hospital

    Redwood City, California, 94062

  • St. Francis Hospital

    Roslyn, New York, 11576

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Morton Plant Hospital

    Safety Harbor, Florida, 34695

  • Intermountain Medical Center

    Salt Lake City, Utah, 84103

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Baptist Hospital Desoto

    Southaven, Mississippi, 38761

  • Deaconess Medical Center

    Spokane, Washington, 99204

  • Heart Clinics Northwest/ Sacred Heart Medical Center

    Spokane, Washington, 99204

  • St. John's Hospital and Memorial Medical Center

    Springfield, Illinois, 62701

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305

  • St. Joseph Medical Center

    Towson, Maryland, 21204

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • Holy Spirit Hospital

    Wormleysburg, Pennsylvania, 17043

Other trials in United States

Australia8 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • The Prince Charles Hospital

    Chermside, Queensland, 4061

  • Monash Medical Center - Cardiovascular Research Centre

    Clayton, Victoria, 03168-

  • St. Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • St. Vincent's Hospital

    Fitzroy, 3065

  • Liverpool Hospital

    New South Wales, 2170

  • Eastern Heart Clinic, The Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • The Princess Alexandra Hospital

    Woolloongabba, Queensland, 4109

Other trials in Australia

Germany8 sites

  • RWTH Aachen

    Aachen, 52074-

  • Charité - Campus Benjamin Franklin

    Berlin

  • St.Johannes Krankenhaus

    Dortmund, 44137

  • UKE Hamburg - Universitätsklinikum Eppendorf

    Hamburg, 20251-

  • Uniklinik Homburg

    Homburg, 66421

  • Leipzig Heart Center

    Leipzig, 04289

  • Uniklinik Mainz - Johannes Gutenberg Universitat

    Mainz, 55131-

  • Krankenhaus Siegburg - Heart Center Siegburg

    Siegburg, 53721

Other trials in Germany

New Zealand2 sites

  • Auckland City Hospital

    Auckland, 1003

  • Christchurch Hospital

    Christchurch

Other trials in New Zealand

About this study

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

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.

Read the 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.

Being tested
ZoMaxx™ Drug-Eluting Coronary Stent System, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Keywords
drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis
Medical subject headings
Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Vascular Diseases, Myocardial Ischemia, Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZoMaxx™ Drug-Eluting Coronary Stent SystemDevice

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

  • TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary StentDevice

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

Study groups in NCT00140101
Study groupRoleWhat they receive
1ExperimentalZoMaxx™ Drug-Eluting Stent System
Receives: Device: ZoMaxx™ Drug-Eluting Coronary Stent System
2Active comparatorTAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System
Receives: Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at 9 months

Secondary outcomes (1)

  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.

    Measured: at 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionSep 2007
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,099 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00140101
Sponsor's protocol ID
640-0048
Other IDs
96039
Acronym
ZoMaxx™ II
Status last verified
Jan 2012
First submitted
30 Aug 2005
Last updated
10 Jan 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21658783

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZoMaxx™ Drug-Eluting Coronary Stent System and TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent in people with Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 92 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, Australia, Germany, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00140101, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2012.

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