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

Coronary Artery Disease Clinical Trial

— ZoMaxx™ II  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00140101
• Other study ID #: 640-0048
• Secondary ID: 96039
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2005
• Last updated: January 6, 2012
• Start date: May 2005
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1099
• Est. completion date: January 2012
• Est. primary completion date: September 2007
• 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

• 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

Study Design

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

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
Drug eluting stent implantation stent in the treatment of coronary artery disease.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	Monash Medical Center - Cardiovascular Research Centre	Clayton	Victoria
Australia	St. Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	St. Vincent's Hospital	Fitzroy
Australia	Liverpool Hospital	New South Wales
Australia	Eastern Heart Clinic, The Prince of Wales Hospital	Randwick	New South Wales
Australia	The Princess Alexandra Hospital	Woolloongabba	Queensland
Germany	RWTH Aachen	Aachen
Germany	Charité - Campus Benjamin Franklin	Berlin
Germany	St.Johannes Krankenhaus	Dortmund
Germany	UKE Hamburg - Universitätsklinikum Eppendorf	Hamburg
Germany	Uniklinik Homburg	Homburg
Germany	Leipzig Heart Center	Leipzig
Germany	Uniklinik Mainz - Johannes Gutenberg Universitat	Mainz
Germany	Krankenhaus Siegburg - Heart Center Siegburg	Siegburg
New Zealand	Auckland City Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch
United States	Emory Crawford Long Hospital	Atlanta	Georgia
United States	Emory Hospital	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	St. Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	Overlake Hospital Medical Center	Bellevue	Washington
United States	North Cascade Cardiology / St. Joseph's Hospital	Bellingham	Washington
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Aultman Health Foundation	Canton	Ohio
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Novant Medical Group	Charlotte	North Carolina
United States	Erlanger Medical Center	Chattanooga	Tennessee
United States	Our Lady of Lourdes Medical Center	Cherry Hill	New Jersey
United States	Rush University Medical Center	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Genesis Medical Center	Davenport	Iowa
United States	University of Colorado	Denver	Colorado
United States	Iowa Heart Center/Methodist Hospital	Des Moines	Iowa
United States	St. John's Hospital	Detroit	Michigan
United States	EMH Regional Medical Center	Elyria	Ohio
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	NE Georgia Medical Center	Gainesville	Georgia
United States	University of Florida Health Science Center	Gainesville	Florida
United States	ACS-Mesa General Hospital	Gilbert	Arizona
United States	Moses H. Cone Memorial Hospital	Greensboro	North Carolina
United States	Pinnacle Health at Harrisburg Hospital	Harrisburg	Pennsylvania
United States	Hartford Hospital	Hartford	Connecticut
United States	St. Luke's Episcopal Hospital	Houston	Texas
United States	Huntsville Hospital	Huntsville	Alabama
United States	Cape Cod Research Institute	Hyannis	Massachusetts
United States	Clarion Health/Methodist Hospital	Indianapolis	Indiana
United States	The Heart Center of IN, LLC	Indianapolis	Indiana
United States	University of Iowa Hospital	Iowa City	Iowa
United States	Univ of Florida Health Science Center Shands	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Foundation for Cardiovascular Medicine	La Jolla	California
United States	Scripps Memorial Hospital	La Jolla	California
United States	Central Baptist Hospital	Lexington	Kentucky
United States	St. Joseph's Hospital Health Center	Liverpool	New York
United States	Lubbock Heart Hospital	Lubbock	Texas
United States	Medical Center of Central GA (MCCG)	Macon	Georgia
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia Presbyterian Hospital	New York	New York
United States	Lenox Hill Hospital	New York	New York
United States	New York Presbyterian Hospital-Cornell	New York City	New York
United States	Oklahoma Heart	Oklahoma City	Oklahoma
United States	Florida Hospital	Orlando	Florida
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Hahnemann University Hospital Drexel University	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Univ of Pittsburgh Medical Center Health System	Pittsburgh	Pennsylvania
United States	Wake Medical Hospital	Raleigh	North Carolina
United States	Sequoia Hospital	Redwood City	California
United States	St. Francis Hospital	Roslyn	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Morton Plant Hospital	Safety Harbor	Florida
United States	Intermountain Medical Center	Salt Lake City	Utah
United States	Swedish Medical Center	Seattle	Washington
United States	Baptist Hospital Desoto	Southaven	Mississippi
United States	Deaconess Medical Center	Spokane	Washington
United States	Heart Clinics Northwest/ Sacred Heart Medical Center	Spokane	Washington
United States	St. John's Hospital and Memorial Medical Center	Springfield	Illinois
United States	Barnes Jewish Hospital	St. Louis	Missouri
United States	Stanford University Medical Center	Stanford	California
United States	St. Joseph Medical Center	Towson	Maryland
United States	Washington Hospital Center	Washington	District of Columbia
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina
United States	Holy Spirit Hospital	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Countries where clinical trial is conducted

United States,  Australia,  Germany,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		at 9 months	Yes
Secondary	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.		at 9 months	Yes