Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232843
Status:
COMPLETED
Last Update Posted:
2009-06-03
First Post:
2005-10-04
Brief Title:
The Study to Treat Superficial Femoral Artery Occlusions
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
A Clinical Investigation of the SMART Nitinol Self-Expandable Stent Versus Balloon Angioplasty Only for the Treatment of SUPERficial Femoral Artery Occlusions
Status:
COMPLETED
Status Verified Date:
2009-06
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:
SUPER UK
Brief Summary:
The main objective of this study is to assess the performance of the Cordis SMART nitinol self-expandable stent for the treatment of superficial femoral artery SFA occlusions in comparison with balloon angioplasty only as determined by binary restenosis at one year
Detailed Description:
This is a multi-center prospective randomized two-arm study evaluating the performance of the Cordis SMART nitinol self-expanding stent as compared to angioplasty only
It is anticipated that a total of 150 patients will be entered into the study Patients will be randomized on a 11 basis of stent versus angioplasty only
150 patients with de novo or restenotic native SFA occlusions 5-22 cm with reference vessel of 40 to 60 mm in diameter will be randomized to the SMART nitinol self-expanding stent or to angioplasty only
All patients will be followed for 12 months post-procedure by telephone contact at 3 and 6 months and a 12 month clinical and duplex ultrasound assessment This study will be conducted at up to 12 investigational sites
It is anticipated that a total of 150 patients will be entered into the study Patients will be randomized on a 11 basis of stent versus angioplasty only
150 patients with de novo or restenotic native SFA occlusions 5-22 cm with reference vessel of 40 to 60 mm in diameter will be randomized to the SMART nitinol self-expanding stent or to angioplasty only
All patients will be followed for 12 months post-procedure by telephone contact at 3 and 6 months and a 12 month clinical and duplex ultrasound assessment This study will be conducted at up to 12 investigational sites
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