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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00148356
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : April 1, 2011
Information provided by:
Abbott Vascular

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.

Condition or disease Intervention/treatment Phase
Coronary Disease Coronary Artery Disease Coronary Restenosis Device: ZoMaxx™ Drug-Eluting Coronary Stent System Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System Phase 2 Phase 3

Detailed Description:

Heart disease is the leading cause of death in Europe as a whole, and while mortality rates for cardiovascular disease have decreased in most western European countries, due to expanded use of prevention strategies and better treatment, coronary heart disease mortality in the middle age groups is increasing rapidly in most of the countries in Eastern Europe. The number of procedures performed to treat cardiovascular disease in Europe is constantly increasing, although different types of procedures are exhibiting different trends. Percutaneous coronary interventions (PCI) procedures, for example, totaled 430,000 in the European Union (15 countries) and 520,000 in Europe as a whole (33 countries) in 2000, as reported by the Euro Heart Survey, and growth is continuing at a rate of more than 20% per year. Despite the effectiveness of intracoronary stents in maintaining a larger luminal diameter as compared to angioplasty alone, 15 - 35% of 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 use 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 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 maximizing systemic drug effects. The ZoMaxx I Trial is a study of the ZoMaxx Drug Eluting Coronary Stent System (ZoMaxx DES) 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  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the ZoMaxx Drug Eluting Coronary Stent System Compared to the TAXUS™ Express2 Paclitaxel-Eluting Coronary Stent System in de Novo Coronary Artery Lesions
Study Start Date : September 2004
Actual Primary Completion Date : May 2006
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

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

Primary Outcome Measures :
  1. The primary end-point is in-segment late-loss at 9 months (as measured by QCA), defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD. [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Target Lesion revascularization(TLR) [ Time Frame: at 9 months ]
  2. Target Vessel Revascularization (TVR) [ Time Frame: at 9 months ]
  3. Target Vessel Failure [ Time Frame: at 9 months ]
  4. Major Adverse Cardiac Events(MACE) defined as Cardiac Death, MI( Q-wave and non Q-wave) or TVR [ Time Frame: at 30 days, 6,9,12 months and anually through 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria include all of the following:

  • Subject is ≥ 18 years old.
  • Female of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment and utilize reliable birth control for nine (9) months after enrollment.
  • Subject is eligible for percutaneous coronary intervention (PCI) and has a single lesion requiring treatment.
  • Subject is an acceptable candidate for CABG.
  • Subject has clinical evidence of ischemic heart disease or a positive functional study.
  • Subject has documented stable angina pectoris

Exclusion Criteria include all of the following:

  • Evidence of an acute myocardial infarction (AMI) or CK-MB > 2x upper limit of normal within 72 hours of the intended treatment (refer to WHO definition).
  • Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, stainless steel, tantalum, contrast agent (that cannot be adequately premedicated), paclitaxel, or drugs similar to ABT-578 (i.e. tacrolimus, sirolimus, everolimus).
  • A platelet count < 100 x 109/L or > 700 x 109/L (< 100,000 cells/mm3 or > 700,000 cells/mm3); a WBC < 3,000 cells/mm3; or a hemoglobin < 10.0 g/dl.
  • Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or > 150 µmol/L).
  • Subject has had any previous or planned brachytherapy in the target vessel.
  • Target vessel has evidence of thrombus or is excessively tortuous (> 60 degree bend) that makes it unsuitable for proper stent delivery and deployment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00148356

  Hide Study Locations
Australia, Victoria
St. Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
Monash Medical Center
Victoria, Australia, 3168
Onze Lieve Vrouw Hospital
Aalst, Belgium, 9300
Middelheim Algemeen Ziekenhuis
Antwerpen, Belgium, 2020
KU Leuven - UZ Gasthuisberg
Leuven, Belgium, 3000
C.H.U. Sart Tilman
Liège, Belgium, 4000
Rigshospitalet / University of Copenhagen
Copenhagen, Denmark, DK-2100
Skejby Sygehus
Århus, Denmark, Aarhus N
Polyclinique les Fleurs
Ollioules, France, 83190
Centre Cardilogique du Nord, 32-36, rue des Moulins Gémeaux
Saint-Denis, France, 93200
Hôpital de Rangueil - CHU
Toulouse, Cedex 9, France, 31059
Clinique Pasteur
Toulouse, France, 31076
Clinique Saint Gatien
Tours, France, 37042
Herzzentrum Bad Krozingen
Bad Krozingen, Germany, 79189
St.Johannes Krankenhaus
Dortmund, Germany, 44137
Universitätsklinikum Essen
Essen, Germany, 45122
Universitätsklinikum Eppendorf
Hamburg, Germany, 20245
Herzzentrum Leipzig
Leipzig, Germany, 04289
Cardiology Practice and Hospital Prof. Silber
Munich, Germany, 81379
Herzzentrum Siegburg GmbH
Siegburg, Germany, 53721
Erasmus Medical Center
Rotterdam, Netherlands, 3015 CE
New Zealand
Auckland City Hospital
Auckland, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Hospital de Santa Cruz
Carnaxide, Portugal, 2790-134
Herzzentrum Bodensee
Kreuzlingen, Switzerland, 8280
La Tour Hospital
Meyrin-Geneva, Switzerland, 1217
University Hospital Zürich
Zürich, Switzerland, 8091
United Kingdom
Barts and the London NHS Trust
London, United Kingdom, E2 9JX
Royal Brompton Hospital
London, United Kingdom, SW36NP
Sponsors and Collaborators
Abbott Vascular
Principal Investigator: Bernard Chevalier, M.D. Centre Cardiologique du Nord

Publications of Results:
Responsible Party: Abbott Vascular Identifier: NCT00148356     History of Changes
Other Study ID Numbers: 640-0047
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: April 1, 2011
Last Verified: March 2011

Keywords provided by Abbott Vascular:
drug eluting stents
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
Arterial Occlusive Diseases
Vascular Diseases
Coronary Stenosis
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action