Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
Study NCT ID:
NCT00561457
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2007-11-20
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System
Sponsor:
C. R. Bard
Organization:
Study Overview
Official Title:
A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System
Status:
COMPLETED
Status Verified Date:
2017-01
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:
Luminexx
Brief Summary:
To determine the safety and effectiveness of the LUMINEXX stent for the proposed indication of treatment of common and/or external iliac artery occlusive disease
Detailed Description:
The study is designed to collect safety and efficacy data on the Bard Luminexx Iliac Stent in a broad patient population having indications for iliac stenting. Effectiveness in this study will be demonstrated by the prevention of Major Adverse Clinical Events (MACE). The composite primary endpoint of this clinical trial is freedom from peri-procedural death and freedom from stented segment revascularization or restenosis (\>50%) at nine months.
Study Oversight
Has Oversight DMC:
False
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?: