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

NCT ID: NCT00148356

Last Updated: 2011-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 401 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2010-10-31

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

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.

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• 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 System

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 System

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

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

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott Vascular

Principal Investigators

Bernard Chevalier, M.D.

Role: PRINCIPAL_INVESTIGATOR

Centre Cardiologique du Nord

Locations

St. Vincent's Hospital

Fitzroy, Victoria, Australia

Monash Medical Center

Victoria, , Australia

Onze Lieve Vrouw Hospital

Aalst, , Belgium

Middelheim Algemeen Ziekenhuis

Antwerp, , Belgium

KU Leuven - UZ Gasthuisberg

Leuven, , Belgium

C.H.U. Sart Tilman

Liège, , Belgium

Skejby Sygehus

Aarhus, , Denmark

Rigshospitalet / University of Copenhagen

Copenhagen, , Denmark

Polyclinique les Fleurs

Ollioules, , France

Centre Cardilogique du Nord, 32-36, rue des Moulins Gémeaux

Saint-Denis, , France

Hôpital de Rangueil - CHU

Toulouse, , France

Clinique Pasteur

Toulouse, , France

Clinique Saint Gatien

Tours, , France

Herzzentrum Bad Krozingen

Bad Krozingen, , Germany

St.Johannes Krankenhaus

Dortmund, , Germany

Universitätsklinikum Essen

Essen, , Germany

Universitätsklinikum Eppendorf

Hamburg, , Germany

Herzzentrum Leipzig

Leipzig, , Germany

Cardiology Practice and Hospital Prof. Silber

Munich, , Germany

Herzzentrum Siegburg GmbH

Siegburg, , Germany

Erasmus Medical Center

Rotterdam, , Netherlands

Auckland City Hospital

Auckland, , New Zealand

Dunedin Hospital

Dunedin, , New Zealand

Hospital de Santa Cruz

Carnaxide, , Portugal

Herzzentrum Bodensee

Kreuzlingen, , Switzerland

La Tour Hospital

Meyrin-Geneva, , Switzerland

University Hospital Zürich

Zurich, , Switzerland

Barts and the London NHS Trust

London, , United Kingdom

Royal Brompton Hospital

London, , United Kingdom

Countries

Australia; Belgium; Denmark; France; Germany; Netherlands; New Zealand; Portugal; Switzerland; United Kingdom

References

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.

Reference Type: RESULT

PMID: 19463354 (View on PubMed)

Other Identifiers

640-0047

Identifier Type: -

Identifier Source: org_study_id