Clinical trial NCT00148356: Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Keywords: drug eluting stents
stents
angioplasty
coronary artery disease
total coronary occlusion
coronary artery restenosis
stent thrombosis
vascular disease
myocardial ischemia
coronary artery stenosis
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 9 months
Secondary outcomes:
measure: Target Lesion revascularization(TLR)
timeFrame: at 9 months
measure: Target Vessel Revascularization (TVR)
timeFrame: at 9 months
measure: Target Vessel Failure
timeFrame: at 9 months
measure: Major Adverse Cardiac Events(MACE) defined as Cardiac Death, MI( Q-wave and non Q-wave) or TVR
timeFrame: at 30 days, 6,9,12 months and anually through 5 years
Other outcomes:
Locations:
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital
state: Victoria
city: Victoria
country: Australia
facility: Monash Medical Center
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Hospital
city: Antwerpen
country: Belgium
facility: Middelheim Algemeen Ziekenhuis
city: Leuven
country: Belgium
facility: KU Leuven - UZ Gasthuisberg
city: Liège
country: Belgium
facility: C.H.U. Sart Tilman
city: Copenhagen
country: Denmark
facility: Rigshospitalet / University of Copenhagen
city: Århus
country: Denmark
facility: Skejby Sygehus
city: Ollioules
country: France
facility: Polyclinique les Fleurs
city: Saint-Denis
country: France
facility: Centre Cardilogique du Nord, 32-36, rue des Moulins Gémeaux
city: Toulouse, Cedex 9
country: France
facility: Hôpital de Rangueil - CHU
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: Clinique Saint Gatien
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Dortmund
country: Germany
facility: St.Johannes Krankenhaus
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Hamburg
country: Germany
facility: Universitätsklinikum Eppendorf
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Munich
country: Germany
facility: Cardiology Practice and Hospital Prof. Silber
city: Siegburg
country: Germany
facility: Herzzentrum Siegburg GmbH
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Carnaxide
country: Portugal
facility: Hospital de Santa Cruz
city: Kreuzlingen
country: Switzerland
facility: Herzzentrum Bodensee
city: Meyrin-Geneva
country: Switzerland
facility: La Tour Hospital
city: Zürich
country: Switzerland
facility: University Hospital Zürich
city: London
country: United Kingdom
facility: Barts and the London NHS Trust
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Centre Cardiologique du Nord
name: Bernard Chevalier, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.