Ignite Creation Date:
2024-05-06 @ 8:43 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02804113
Status:
COMPLETED
Last Update Posted:
2021-01-06
First Post:
2016-06-14
Brief Title:
Clinical Trial Investigating the Efficacy of the Supera Peripheral Stent System for the Treatment of the Common Femoral Artery
Sponsor:
ID3 Medical
Organization:
ID3 Medical
Study Overview
Official Title:
VMI-CFA Study Physician-initiated Trial Investigating the Efficacy of the Vascular Mimetic Implant Supera Peripheral Stent System for the Treatment of the Common Femoral Artery
Status:
COMPLETED
Status Verified Date:
2021-01
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:
VMI-CFA
Brief Summary:
The VMI-CFA study investigates the efficacy of the Supera Stent in the treatment of common femoral artery stenosis or occlusion 100 patients will be included with a RF of 2 to 4 The lesion is located within the native CFA and treated with predillation prior to stenting with the Supera Peripheral Stent System Patients will be invited for a follow-up visit at 1 6 12 and 24 month post procedure The primary endpoint of the study is the primary patency at 12 months and periprocedural events up to 30 days post procedure Secondary endpoints include technical success primary patency rate at 1 6 and 24 month freedom from TLR at 1- 6- 12 and 24 month follow-up and clinical success at 1- 6- 12- and 24-month follow-up
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