Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148356
Status:
COMPLETED
Last Update Posted:
2011-04-01
First Post:
2005-09-06
Brief Title:
Safety and Efficacy of the ZoMaxx Drug-Eluting Stent System in Coronary Arteries
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
A Randomized Controlled Trial to Evaluate the Safety and Efficacy of the ZoMaxx Drug Eluting Coronary Stent System Compared to the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System in de Novo Coronary Artery Lesions
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZoMaxx I
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:
Heart disease is the leading cause of death in Europe as a whole and while mortality rates for cardiovascular disease have decreased in most western European countries due to expanded use of prevention strategies and better treatment coronary heart disease mortality in the middle age groups is increasing rapidly in most of the countries in Eastern Europe The number of procedures performed to treat cardiovascular disease in Europe is constantly increasing although different types of procedures are exhibiting different trends Percutaneous coronary interventions PCI procedures for example totaled 430000 in the European Union 15 countries and 520000 in Europe as a whole 33 countries in 2000 as reported by the Euro Heart Survey and growth is continuing at a rate of more than 20 per year Despite the effectiveness of intracoronary stents in maintaining a larger luminal diameter as compared to angioplasty alone 15 - 35 of 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 use 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 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 maximizing systemic drug effects The ZoMaxx I Trial is a study of the ZoMaxx Drug Eluting Coronary Stent System ZoMaxx DES 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 US law to investigational use only
ZoMaxx Drug-Eluting Stent System is an Investigational device Limited by Federal US law to investigational use only
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None