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

Sponsored by:	Abbott Vascular
Information provided by:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT00140101

Purpose

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.

Condition	Intervention	Phase
Coronary Disease Coronary Artery Disease Coronary Restenosis	Device: ZoMaxx™ Drug-Eluting Coronary Stent System Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent	Phase II

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:

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. [ Time Frame: at 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: at 9 months ] [ Designated as safety issue: Yes ]

Enrollment:	1099
Study Start Date:	May 2005
Estimated Study Completion Date:	August 2011
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental ZoMaxx™ Drug-Eluting Stent System	Device: ZoMaxx™ Drug-Eluting Coronary Stent System Drug eluting stent implantation stent in the treatment of coronary artery disease.
2: Active Comparator TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System	Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent Drug eluting stent implantation stent in the treatment of coronary artery disease.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140101

Show 37 Study Locations

Sponsors and Collaborators

Abbott Vascular

Investigators

Principal Investigator:	Alan Yeung, M.D.	Stanford University
Study Director:	David Lee, M.D.	Stanford University

More Information

Responsible Party:	Abbott Vascular ( Abbott Vascular )
Study ID Numbers:	640-0048, 96039
Study First Received:	August 30, 2005
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00140101
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott Vascular:

drug eluting stents
stents
angioplasty
coronary artery disease
total coronary occlusion

coronary artery restenosis
stent thrombosis
vascular disease
myocardial ischemia
coronary artery stenosis

Study placed in the following topic categories:

Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Constriction, Pathologic
Ischemia
Arteriosclerosis

Coronary Restenosis
Coronary Stenosis
Thrombosis
Coronary Disease
Coronary Occlusion
Paclitaxel
Coronary Artery Disease

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators

Cardiovascular Diseases
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009