Ignite Creation Date:
2024-05-05 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00744107
Status:
UNKNOWN
Last Update Posted:
2009-08-06
First Post:
2008-08-27
Brief Title:
Cobra II Study Use of the Cobra Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease
Sponsor:
Medlogics Device Corporation
Organization:
Medlogics Device Corporation
Study Overview
Official Title:
The Cobra II Study Use of the Cobra Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease
Status:
UNKNOWN
Status Verified Date:
2009-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
To demonstrate the safety and efficacy of the Cobra Cobalt Super Alloy Balloon-Expandable Coronary Stent System for the treatment of de novo and restenotic previously unstented lesions in native coronary arteries in subjects with coronary artery disease CAD having a reference vessel diameter RVD between 25 - 40 mm and a lesion length 26 mm amenable to percutaneous coronary intervention PCI with a single stent in subjects with symptomatic ischemic heart disease
Detailed Description:
Safety and Efficacy will be demonstrated by the rate of Target vessel failure TVF defined as cardiac death target vessel myocardial infarction MI Q wave or non-Q wave or clinically driven target vessel revascularization TVR by percutaneous or surgical methods within 270 days of the post-stent placement procedure
Additionally Major Adverse Cardiac Events MACEat 30 180 and 270 days defined as a composite of all-cause death myocardial infarction MI Q wave and non-Q wave emergent bypass surgery or clinically driven target lesion revascularization TLR percutaneous coronary intervention PCI or coronary artery bypass graft CABGwill be documented
Additionally Major Adverse Cardiac Events MACEat 30 180 and 270 days defined as a composite of all-cause death myocardial infarction MI Q wave and non-Q wave emergent bypass surgery or clinically driven target lesion revascularization TLR percutaneous coronary intervention PCI or coronary artery bypass graft CABGwill be documented
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