Actively Recruiting
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
Led by Efemoral Medical, Inc. · Updated on 2026-03-25
100
Participants Needed
8
Research Sites
492 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic peripheral vascular occlusive disease classified as Rutherford-Becker Clinical Category 2 to 4
- Life expectancy longer than 36 months
- Negative pregnancy test for females who can become pregnant
- Ability to provide informed consent
- Agreement to complete all required follow-up visits at the study site
- Ability to take antiplatelet and/or anticoagulant medications as prescribed
- Single new disease segment in the superficial femoral artery or P1 popliteal artery
- Vessel diameter between 5.5 mm and 6.5 mm
- Target lesion length up to 90 mm
- Lesion with at least 50% diameter stenosis
- No significant narrowing (less than 50% stenosis) in inflow and popliteal arteries
You will not qualify if you...
- Hemoglobin less than 9.0 g/dL
- White blood cell count less than 3,000 cells/mm3
- Platelet count less than 80,000 cells/mm3 or greater than 700,000 cells/mm3
- Acute or chronic kidney dysfunction with creatinine above 2.5 mg/dL
- Severe liver impairment indicated by high bilirubin or liver enzymes
- Allergy or contraindication to aspirin, heparin, bivalirudin, ticagrelor, or sirolimus
- Contrast dye sensitivity that cannot be treated
- Planned procedures requiring stopping antiplatelet therapy
- Inability to walk
- Vascular intervention within 30 days before planned treatment
- Chronic hemodialysis
- Uncontrolled diabetes with HbA1c of 7.0% or higher
- Heart attack or stroke within 30 days before planned treatment
- Unstable angina with ECG changes
- Untreated or ongoing local or systemic infection
- Acute thrombophlebitis, deep vein thrombosis, or chronic venous insufficiency
- Serious medical illnesses affecting compliance or study completion
- Participation in conflicting investigational studies
- Ischemic or neuropathic ulcers on either foot
- Prior amputation of either lower limb
- Unable to give informed consent
- Significant lesion distal to target needing treatment
- Acute arterial ischemia in target limb
- Previous surgical revascularization of target limb
- Previous stent or atherectomy treatment in target vessel
- Complete blockage of the ipsilateral inflow artery
- Thrombus in target vessel
- Need for devices other than balloon angioplasty
- Lesion within or near an aneurysm
- Evidence of embolism from iliac lesion treatment
- Moderate to severe lesion calcification
- More than 30% residual narrowing after pre-dilatation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Northern Health
Sydney, New South Wales, Australia
Actively Recruiting
2
Canberra Hospital
Canberra, Australia
Actively Recruiting
3
The Alfred Hospital
Melbourne, Australia
Actively Recruiting
4
Prince Of Wales Hospital
Sydney, Australia
Actively Recruiting
5
Royal North Shore
Sydney, Australia
Actively Recruiting
6
Auckland City Hospital
Auckland, New Zealand, 1142
Actively Recruiting
7
Christchurch Hospital
Christchurch, New Zealand
Actively Recruiting
8
Waikato Hospital
Hamilton, New Zealand
Actively Recruiting
Research Team
L
Lew Schwartz, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here