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

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

To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery

Study Overview

• Status: Recruiting
• Conditions: Vascular Diseases; Peripheral Arterial Disease; Stenosis; Femoropopliteal Stenosis
• Intervention / Treatment: Device: Efemoral Vascular Scaffold System (EVSS)

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lew Schwartz, MD; Phone Number: 224-707-2601; Email: lewis.schwartz@efemoralmedical.com

Study Locations

• Australia
  • Canberra, Australia
    • Recruiting
    • Canberra Hospital
    • Contact: Dr Gert Frahm-Jensen
  • Melbourne, Australia
    • Recruiting
    • The Alfred Hospital
    • Contact: Dr Gerard Goh
  • Sydney, Australia
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Ramon Varcoe, MD
  • Sydney, Australia
    • Recruiting
    • Royal North Shore
    • Contact: Dr Vikram Puttaswamy
  • New South Wales
    • Sydney, New South Wales, Australia
      • Recruiting
      • Northern Health
      • Contact: Dr Shrikkanth Rangarajan
• New Zealand
  • Auckland, New Zealand, 1142
    • Recruiting
    • Auckland City Hospital
    • Contact: Andrew Holden, MD; Phone Number: 6493670000; Email: andrewh@adhb.govt.nz
  • Christchurch, New Zealand
    • Recruiting
    • Christchurch Hospital
    • Contact: Ruth Benson, MD
  • Hamilton, New Zealand
    • Recruiting
    • Waikato Hospital
    • Contact: Manar Khashram, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Symptomatic peripheral vascular occlusive disease (Rutherford-Becker Clinical Category 2-4)
• Patient with life expectancy >36 months
• Females of childbearing potential must have negative pregnancy test
• Patient is able to provide informed consent
• Patient agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.
• Patient must be able to take antiplatelet and/or anticoagulant agents as prescribed
• Single de novo native disease segment of the superficial femoral artery (SFA) or P1 popliteal segment
• Reference vessel diameter ≥5.5 mm and ≤6.5 mm
• Target lesion length ≤90 mm
• Target lesion with ≥50% DS
• Inflow artery and popliteal artery free from flow-limiting lesion (DS <50%)

Exclusion Criteria:

• Hemoglobin <9.0 g/dL
• WBC <3,000 cells/mm3
• Platelet count <80,000 cells/mm3 or >700,000 cells/mm3
• Acute or chronic renal dysfunction with creatinine >2.5 mg/dl (176 µmol/L)
• Severe liver impairment as defined by total bilirubin ≥3 mg/dl or two times increase over the normal level of SGOT or SGPT
• A known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticagrelor or sirolimus, or with contrast sensitivity for which the patient cannot be adequately pre-medicated
• Patient requires a planned procedure that would necessitate discontinuation of antiplatelet therapy
• Patient is unable to walk
• Patient has undergone a percutaneous vascular intervention <30 days prior to the planned index procedure
• Patient is maintained on chronic hemodialysis
• Patient has uncontrolled diabetes mellitus (HbA1c ≥7.0%).
• Patient has had a myocardial infarction within the previous 30 days of the planned index procedure
• Patient has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limits the patient's ability to walk
• Patient has unstable angina defined as rest angina with ECG changes
• Patient has a local groin or acute systemic infection that has not been treated successfully or is currently under treatment
• Patient has acute thrombophlebitis, deep vein thrombosis or chronic venous insufficiency in either extremity
• Patient has other medical illnesses (e.g., cancer, congestive cardiomyopathy, etc.) that may cause the patient to be non-compliant with protocol requirements, confound the data interpretation or will prevent completion of all required follow up assessments through 36 months
• Patient is currently participating in an investigational drug, biologic, or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
• Patient has ischemic or neuropathic ulcers on either foot
• Patient has undergone minor or major amputation of either lower extremity
• Patient is part of a vulnerable population who, in the judgment of the Investigator, is unable to give informed consent
• Target extremity with an angiographically significant (>50% DS) lesion located distal to the target lesion that requires treatment at the time of the index procedure or by a staged procedure
• Acute arterial ischemia of the target extremity
• Target extremity has been previously treated with open surgical revascularization (bypass or endarterectomy)
• Target vessel has been previously treated with stent, laser, atherectomy, surgical bypass, or endarterectomy
• Total occlusion (100% DS) of the ipsilateral inflow artery
• Angiographic evidence of thrombus in the target vessel
• The target lesion requires treatment with a device other than percutaneous transluminal balloon angioplasty (PTA) [e.g., orbital atherectomy, directional atherectomy, excimer laser, rotational atherectomy, cryoplasty, etc.]
• Target lesion is within or adjacent to an aneurysm
• Patient has angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion or from crossing or pre-dilating the target lesion
• Target lesion has moderate-to-severe calcification
• Target lesion with > 30% residual stenosis following pre-dilatation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EVSS; Efemoral Vascular Scaffold System (EVSS)	Device: Efemoral Vascular Scaffold System (EVSS); Balloon-expandable, bioresorbable vascular scaffolds coated with sirolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major Adverse Event (MAE)	30 days
Freedom from Binary Restenosis	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success	Achievement of successful delivery and deployment of the study device(s) at the intended target lesion	Day 0
Primary patency rate		1, 6, 12, 24 and 36 months
Binary restenosis rate		1, 6, 12, 24 and 36 months
Target lesion revascularization (TLR)		1, 6, 12, 24 and 36 months
Ipsilateral extremity revascularization (IER)		1, 6, 12, 24 and 36 months
Number of patients with Scaffold thrombosis		through 1 month
Number of patients with scaffold occlusion		6, 12, 24 and 36 months
Rate of Major Adverse Limb Events		through 36 months
Ankle-brachial index (ABI) of target extremity		1, 6, 12, 24 and 36 months
Limb salvage of target extremity		1, 6, 12, 24 and 36 months
Rutherford-Becker Clinical Category for the target extremity		1, 6, 12, 24 and 36 months
Walking impairment as assessed by Walking Impairment Questionnaire (WIQ)		1, 6, 12, 24 and 36 months
Clinical Success	Attainment of a final residual stenosis of <30% using the study device(s) and/or any adjunctive device at the intended target lesion without complications	Up to 2 days after procedure
Technical Success	Attainment of a final residual stenosis of <30% at the intended target lesion(	Day 0

Other Outcome Measures

Outcome Measure	Time Frame
Target lesion percent mean diameter stenosis	Post procedure (Day 0) and 6 months
Target lesion percent maximum diameter stenosis	post procedure (day 0) and at 6 months
Target lesion late lumen loss	6 months
Ischemia-driven target lesion revascularization (IDTLR)	1, 6, 12, 24 and 36 months
Amputation (minor and major) of the target extremity	1, 6, 12, 24 and 36 months

Collaborators and Investigators

• Sponsor: Efemoral Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2020
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Peripheral Artery Disease; Bioresorbable
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathological Conditions, Anatomical; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Pathological Conditions, Signs and Symptoms; Constriction, Pathologic; Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: CL05122020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No