Clinical trial NCT00140101: 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 as Compared to the TAXUS™ Express2™ Paclitaxel-Eluting Stent in de Novo Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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: 2005-09-01
Enrollment: 1099
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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: Coronary artery disease is the major cause of morbidity and mortality in the United States. The American Heart Association estimates that 571,000 Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures were performed in 2001 in the United States and that 80% to 90% of these patients also underwent stent placement. Despite the effectiveness of intracoronary stents in maintaining a larger luminal diameter as compared to angioplasty alone, 15 to 35% 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 delivery 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 in-stent 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 minimizing systemic drug effects. The ZoMaxx II Trial represents the first US study of the ZoMaxx(TM) Drug Eluting Coronary Stent System 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
* Subject is eligible for percutaneous coronary intervention (PCI) and has a single lesion requiring treatment
* Subject is an acceptable candidate for CABG
* Clinical evidence of ischemic heart disease or a positive functional study
* Documented stable angina pectoris
* The target lesion is a single de novo coronary artery lesion with ≥50 and \<100% stenosis by visual estimate

Exclusion Criteria include all of the following:

* Female of childbearing potential. Female subjects must be medically or surgically sterile or diagnosed as post-menopausal (i.e. one year since final menstrual cycle.
* Evidence of an acute myocardial infarction and/or CK-MB\>2x upper limit of normal within 72 hours of the intended treatment
* Known allergies to the following: aspirin, clopidogrel (Plavix) or ticlopidine (Ticlid), heparin, stainless steel, tantalum, contrast agent (that cannot be adequately premedicated), paclitaxel or drugs similar to zotarolimus (ABT-578) (i.e. tacrolimus, sirolimus, everolimus)
* A platelet count \<100,000 cells/mm3or \>700,000 cells/mm3; a WBC \<3,000 cells/mm3; or hemoglobin \<10.0g/dL
* Acute or chronic renal dysfunction (creatinine \>2.0 mg/dl or \>150µmol/L)
* Subject has had any previous or planned brachytherapy in the target vessel

Primary outcomes:
measure: The primary endpoint is TVR (Target Vessel Revascularization). TVR is defined as any ischemia driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.
timeFrame: at 9 months
Secondary outcomes:
measure: The major secondary endpoint is in-segment late loss as measured by QCA. In-segment late loss is defined as the difference between the post-procedure minimal luminal diameter (MLD) and the follow-up angiography MLD.
timeFrame: at 9 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Huntsville Hospital
state: Alabama
city: Gilbert
country: United States
facility: ACS-Mesa General Hospital
state: Arizona
city: La Jolla
country: United States
facility: Foundation for Cardiovascular Medicine
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Redwood City
country: United States
facility: Sequoia Hospital
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida Health Science Center
state: Florida
city: Jacksonville
country: United States
facility: Univ of Florida Health Science Center Shands
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Safety Harbor
country: United States
facility: Morton Plant Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory Crawford Long Hospital
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Hospital
state: Georgia
city: Atlanta
country: United States
facility: St. Joseph's Hospital of Atlanta
state: Georgia
city: Gainesville
country: United States
facility: NE Georgia Medical Center
state: Georgia
city: Macon
country: United States
facility: Medical Center of Central GA (MCCG)
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Peoria
country: United States
facility: OSF St. Francis Medical Center
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital and Memorial Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Clarion Health/Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: The Heart Center of IN, LLC
state: Indiana
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Iowa Heart Center/Methodist Hospital
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospital
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Towson
country: United States
facility: St. Joseph Medical Center
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Hyannis
country: United States
facility: Cape Cod Research Institute
state: Massachusetts
city: Detroit
country: United States
facility: St. John's Hospital
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Southaven
country: United States
facility: Baptist Hospital Desoto
state: Mississippi
city: St. Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Cherry Hill
country: United States
facility: Our Lady of Lourdes Medical Center
state: New Jersey
city: Liverpool
country: United States
facility: St. Joseph's Hospital Health Center
state: New York
city: New York City
country: United States
facility: New York Presbyterian Hospital-Cornell
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Hospital
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Charlotte
country: United States
facility: Novant Medical Group
state: North Carolina
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hospital
state: North Carolina
city: Raleigh
country: United States
facility: Wake Medical Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Canton
country: United States
facility: Aultman Health Foundation
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Elyria
country: United States
facility: EMH Regional Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart
state: Oklahoma
city: Harrisburg
country: United States
facility: Pinnacle Health at Harrisburg Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hahnemann University Hospital Drexel University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Univ of Pittsburgh Medical Center Health System
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Holy Spirit Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Lubbock
country: United States
facility: Lubbock Heart Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain Medical Center
state: Utah
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Bellevue
country: United States
facility: Overlake Hospital Medical Center
state: Washington
city: Bellingham
country: United States
facility: North Cascade Cardiology / St. Joseph's Hospital
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Spokane
country: United States
facility: Deaconess Medical Center
state: Washington
city: Spokane
country: United States
facility: Heart Clinics Northwest/ Sacred Heart Medical Center
state: Washington
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital Sydney
state: New South Wales
city: Randwick
country: Australia
facility: Eastern Heart Clinic, The Prince of Wales Hospital
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: The Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Center - Cardiovascular Research Centre
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital
city: New South Wales
country: Australia
facility: Liverpool Hospital
city: Aachen
country: Germany
facility: RWTH Aachen
city: Berlin
country: Germany
facility: Charité - Campus Benjamin Franklin
city: Dortmund
country: Germany
facility: St.Johannes Krankenhaus
city: Hamburg
country: Germany
facility: UKE Hamburg - Universitätsklinikum Eppendorf
city: Homburg
country: Germany
facility: Uniklinik Homburg
city: Leipzig
country: Germany
facility: Leipzig Heart Center
city: Mainz
country: Germany
facility: Uniklinik Mainz - Johannes Gutenberg Universitat
city: Siegburg
country: Germany
facility: Krankenhaus Siegburg - Heart Center Siegburg
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
Study officials:
affiliation: Stanford University
name: Alan Yeung, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: David Lee, M.D.
role: STUDY_DIRECTOR
References:
citation: Gray WA, Yeung AC, Cutlip DE, Popma JJ, Fitzgerald PJ, Williams DO, Heuer H, O'Shaughnessy CD, Overlie PA, Mann JT, Cannon LA, Hermiller JB, Henry TD, Whitbourn R, Stuckey TD, Midei MG, Coe J, Schwartz LB. A randomized, controlled, multi-center trial comparing the safety and efficacy of zotarolimus-eluting and paclitaxel-eluting stents in de novo lesions in coronary arteries: final results of the ZoMaxx II trial. Int J Cardiol. 2012 May 17;157(1):96-101. doi: 10.1016/j.ijcard.2011.05.061. Epub 2011 Jun 11.