Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228384
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2005-09-26
Brief Title:
GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study
Sponsor:
WLGore Associates
Organization:
WLGore Associates
Study Overview
Official Title:
GORE VIABAHN Endoprosthesis Versus Bare Nitinol Stent in the Treatment of Long Lesion 8cm Superficial Femoral Artery Occlusive Disease
Status:
COMPLETED
Status Verified Date:
2012-05
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:
None
Brief Summary:
To evaluate the performance of the GORE VIABAHN Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery SFA occlusive disease in long lesions
Detailed Description:
This is a multicenter prospective randomized study with clinical and radiographic follow-up for three years post-procedure Approximately one hundred fifty subjects will be enrolled and randomized into one of two study treatment groups
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