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

Coronary Artery Disease Clinical Trial

— ZoMaxx™ I  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148356
• Other study ID #: 640-0047
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 6, 2005
• Last updated: March 31, 2011
• Start date: September 2004
• Est. completion date: October 2010

Study information

• Verified date: March 2011
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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 recognized standard of care.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: October 2010
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Myocardial Ischemia

Intervention

Device:
• ZoMaxx™ Drug-Eluting Coronary Stent System
Drug eluting stent implantation stent in the treatment of coronary artery disease.
• TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System
Drug eluting stent implantation stent in the treatment of coronary artery disease.

Locations

Country	Name	City	State
Australia	St. Vincent's Hospital	Fitzroy	Victoria
Australia	Monash Medical Center	Victoria
Belgium	Onze Lieve Vrouw Hospital	Aalst
Belgium	Middelheim Algemeen Ziekenhuis	Antwerpen
Belgium	KU Leuven - UZ Gasthuisberg	Leuven
Belgium	C.H.U. Sart Tilman	Liège
Denmark	Skejby Sygehus	Århus
Denmark	Rigshospitalet / University of Copenhagen	Copenhagen
France	Polyclinique les Fleurs	Ollioules
France	Centre Cardilogique du Nord, 32-36, rue des Moulins Gémeaux	Saint-Denis
France	Clinique Pasteur	Toulouse
France	Hôpital de Rangueil - CHU	Toulouse, Cedex 9
France	Clinique Saint Gatien	Tours
Germany	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
Netherlands	Erasmus Medical Center	Rotterdam
New Zealand	Auckland City Hospital	Auckland
New Zealand	Dunedin Hospital	Dunedin
Portugal	Hospital de Santa Cruz	Carnaxide
Switzerland	Herzzentrum Bodensee	Kreuzlingen
Switzerland	La Tour Hospital	Meyrin-Geneva
Switzerland	University Hospital Zürich	Zürich
United Kingdom	Barts and the London NHS Trust	London
United Kingdom	Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Countries where clinical trial is conducted

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

References & Publications (1)

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 effic — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Target Lesion revascularization(TLR)		at 9 months	Yes
Secondary	Target Vessel Revascularization (TVR)		at 9 months	Yes
Secondary	Target Vessel Failure		at 9 months	Yes
Secondary	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	Yes