Ignite Creation Date:
2024-05-05 @ 11:32 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01355406
Status:
COMPLETED
Last Update Posted:
2018-06-29
First Post:
2011-05-16
Brief Title:
Evaluation of Safety and Efficacy of the FlexStent Femoropopliteal Self-Expanding Stent System
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
Evaluation of Safety and Efficacy of the FlexStent Femoropopliteal Self-Expanding Stent System Study
Status:
COMPLETED
Status Verified Date:
2018-06
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:
OPEN
Brief Summary:
This is a clinical study of a new self-expanding stent FlexStent designed specifically to cope with the extreme demands of the superficial femoral artery SFAproximal popliteal artery The arteries are often abbreviated as femoropopliteal
The intent of this study is to demonstrate that the FlexStent Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease Specifically the FlexStent shall meet or exceed the proposed safety and efficacy performance goals established for Femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease
The intent of this study is to demonstrate that the FlexStent Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease Specifically the FlexStent shall meet or exceed the proposed safety and efficacy performance goals established for Femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease
Detailed Description:
None
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