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

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

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: Coronary Artery Disease; Coronary Disease; Coronary Restenosis
• Intervention / Treatment: Device: ZoMaxx™ Drug-Eluting Coronary Stent System; Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System

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
• Enrollment (Actual): 401
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

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.
• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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 System; 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 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.	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Target Lesion revascularization(TLR)	at 9 months
Target Vessel Revascularization (TVR)	at 9 months
Target Vessel Failure	at 9 months
Major Adverse Cardiac Events(MACE) defined as Cardiac Death, MI( Q-wave and non Q-wave) or TVR	at 30 days, 6,9,12 months and anually through 5 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Bernard Chevalier, M.D., Centre Cardiologique du Nord

Publications and helpful links

General Publications

• Chevalier B, Di Mario C, Neumann FJ, Ribichini F, Urban P, Popma JJ, Fitzgerald PJ, Cutlip DE, Williams DO, Ormiston J, Grube E, Whitbourn R, Schwartz LB; ZoMaxx I Investigators. A randomized, controlled, multicenter trial to evaluate the safety and efficacy of zotarolimus- versus paclitaxel-eluting stents in de novo occlusive lesions in coronary arteries The ZoMaxx I trial. JACC Cardiovasc Interv. 2008 Oct;1(5):524-32. doi: 10.1016/j.jcin.2008.08.010.

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): May 1, 2006
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: September 6, 2005
• First Submitted That Met QC Criteria: September 6, 2005
• First Posted (Estimate): September 8, 2005

Study Record Updates

• Last Update Posted (Estimate): April 1, 2011
• Last Update Submitted That Met QC Criteria: March 31, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: coronary artery disease; stents; angioplasty; drug eluting stents; stent thrombosis; myocardial ischemia; vascular disease; total coronary occlusion; coronary artery restenosis; coronary artery stenosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Stenosis; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Restenosis; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: 640-0047