NCT04584632

The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Efemoral Medical, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease
• Vascular Diseases
• Stenosis
• Femoropopliteal Stenosis

Interventions

Type	Name	Description
DEVICE	Efemoral Vascular Scaffold System (EVSS)	Balloon-expandable, bioresorbable vascular scaffolds coated with sirolimus

Timeline

• Start date: 2020-09-22
• Primary completion: 2028-03-01
• Completion: 2030-03-01
• First posted: 2020-10-14
• Last updated: 2026-03-25

Locations

8 sites across 2 countries: Australia, New Zealand