Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT04584632
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2020-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients with Symptomatic Peripheral Vascular Disease from Stenosis or Occlusion of the Femoropopliteal Artery
Sponsor:
Efemoral Medical, Inc.
Organization:
Study Overview
Official Title:
A Clinical Evaluation of the Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients with Symptomatic Peripheral Vascular Disease from Stenosis or Occlusion of the Femoropopliteal Artery
Status:
RECRUITING
Status Verified Date:
2025-02
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:
Efemoral I
Brief Summary:
To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery
Detailed Description:
The EFEMORAL I study is a prospective, single-arm, open-labeled, multi-center, clinical investigation enrolling patients with arterial diameter of ≥5.5 mm and ≤6.5 mm and lesion length ≤90 mm receiving a single EVSS.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: