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

Phase 2

Completed

• Conditions: Coronary Disease; Coronary Artery Disease; Coronary Restenosis

• Registration Number: NCT00148356
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Primary Completion: 2006-05
• Study Completion: 2010-10
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-31
• Last Update Posted: 2011-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 401

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Target Lesion revascularization(TLR)	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
Target Vessel Revascularization (TVR)	at 9 months
Target Vessel Failure	at 9 months

Trial Locations

Locations (29)

St. Vincent's Hospital; 🇦🇺 Fitzroy, Victoria, Australia

Monash Medical Center; 🇦🇺 Victoria, Australia

Onze Lieve Vrouw Hospital; 🇧🇪 Aalst, Belgium

Middelheim Algemeen Ziekenhuis; 🇧🇪 Antwerpen, Belgium

KU Leuven - UZ Gasthuisberg; 🇧🇪 Leuven, Belgium

C.H.U. Sart Tilman; 🇧🇪 Liège, Belgium

Rigshospitalet / University of Copenhagen; 🇩🇰 Copenhagen, Denmark

Skejby Sygehus; 🇩🇰 Århus, Denmark

Polyclinique les Fleurs; 🇫🇷 Ollioules, France

Centre Cardilogique du Nord, 32-36, rue des Moulins Gémeaux; 🇫🇷 Saint-Denis, France

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