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

Tracking Information
First Submitted Date ICMJE	August 30, 2005
First Posted Date ICMJE	September 1, 2005
Last Update Posted Date	January 10, 2012
Study Start Date ICMJE	May 2005
Actual Primary Completion Date	September 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 14, 2008)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: August 30, 2005)	The primary endpoint is TVR (Target Vessel Revascularization)at 9 months post procedure. TVR is defined as any ischemia driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.
Change History	Complete list of historical versions of study NCT00140101 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 14, 2008)	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 ]
Original Secondary Outcome Measures ICMJE; (submitted: August 30, 2005)	The major secondary endpoint is in-segment late loss at 9 months 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.
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
Official Title ICMJE	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
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Prevention
Condition ICMJE	Coronary Disease; Coronary Artery Disease; Coronary Restenosis
Intervention ICMJE	Device: ZoMaxx™ Drug-Eluting Coronary Stent System Drug eluting stent implantation stent in the treatment of coronary artery disease.; Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent Drug eluting stent implantation stent in the treatment of coronary artery disease.
Study Arms	Experimental: 1 ZoMaxx™ Drug-Eluting Stent System Intervention: Device: ZoMaxx™ Drug-Eluting Coronary Stent System; Active Comparator: 2 TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System Intervention: Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 14, 2008)	1099
Original Enrollment ICMJE; (submitted: August 30, 2005)	1670
Actual Study Completion Date	January 2012
Actual Primary Completion Date	September 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Australia, Germany, New Zealand, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00140101
Other Study ID Numbers ICMJE	640-0048; 96039
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Abbott Vascular
Study Sponsor ICMJE	Abbott Vascular
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Alan Yeung, M.D. Stanford University Study Director: David Lee, M.D. Stanford University
PRS Account	Abbott Vascular
Verification Date	January 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP