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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00148356
Other study ID # 640-0047
Secondary ID
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


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
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