Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140101
Status:
COMPLETED
Last Update Posted:
2012-01-10
First Post:
2005-08-30
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 as Compared to the TAXUS Express2 Paclitaxel-Eluting Stent in de Novo Coronary Artery Lesions
Status:
COMPLETED
Status Verified Date:
2012-01
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 II
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 571000 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 ZoMaxxTM 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 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 96039 | None | None | None |