Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00289055
Status:
TERMINATED
Last Update Posted:
2009-02-24
First Post:
2006-02-07
Brief Title:
The Study to Compare the Treatment of Angioplasty and Stents in SFA Occlusions
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
A Clinical Investigation of the SMART Nitinol Self-Expandable Stent Versus Balloon Angioplasty for the Treatment of Superficial Femoral Artery Occlusions
Status:
TERMINATED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DURAVEST
Brief Summary:
The main objective of this study is to assess the patency rate of the nitinol self-expandable stent device in the treatment of superficial femoral artery SFA occlusions as compared to angioplasty only
Detailed Description:
This is a multi-center prospective randomized two-arm study evaluating performance of the Cordis SMART nitinol self-expanding stent as compared to balloon angioplasty only Patients will be randomized on a 11 basis It is anticipated that a total of 120 patients will be entered into the study
The study population will consist of symptomatic peripheral vascular disease patients with SFA occlusions The disease will consist of symptomatic long de novo or restenotic occlusions 5 - 145 cm on diagnostic imaging with a history of at least 6 months The occlusions must not extend beyond the proximal popliteal artery For the purpose of this protocol no lesion within 3 cm of the upper part of the patella may be treated The distal popliteal artery must be patent with no hemodynamic stenosis as well as two calf vessels Reference vessel diameter must be 40 to 60 mm
Trial participants will be randomized to the SMART nitinol self-expanding stent or to balloon angioplasty only
Patients will be followed for twelve months post-procedure Study examinations will be done at screening procedure time discharge six and twelve months post procedure
This study will be conducted at 8 investigational sites in The Netherlands
The study population will consist of symptomatic peripheral vascular disease patients with SFA occlusions The disease will consist of symptomatic long de novo or restenotic occlusions 5 - 145 cm on diagnostic imaging with a history of at least 6 months The occlusions must not extend beyond the proximal popliteal artery For the purpose of this protocol no lesion within 3 cm of the upper part of the patella may be treated The distal popliteal artery must be patent with no hemodynamic stenosis as well as two calf vessels Reference vessel diameter must be 40 to 60 mm
Trial participants will be randomized to the SMART nitinol self-expanding stent or to balloon angioplasty only
Patients will be followed for twelve months post-procedure Study examinations will be done at screening procedure time discharge six and twelve months post procedure
This study will be conducted at 8 investigational sites in The Netherlands
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