Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries (ZoMaxx™ II)
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 30, 2005 | ||||||||
| Last Updated Date | January 6, 2012 | ||||||||
| Start Date ICMJE | May 2005 | ||||||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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 |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 1099 | ||||||||
| Completion Date | January 2012 | ||||||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria include all of the following:
Exclusion Criteria include all of the following:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Listed Location Countries ICMJE | United States, Australia, Germany, New Zealand | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00140101 | ||||||||
| Other Study ID Numbers ICMJE | 640-0048, 96039 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Abbott Vascular | ||||||||
| Study Sponsor ICMJE | Abbott Vascular | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Abbott Vascular | ||||||||
| Verification Date | January 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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