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

NCT04584632 | Recruiting DMC

• 1 other identifier: CL05122020
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 8

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

Conditions

Peripheral Arterial Disease; Vascular Diseases; Stenosis; Femoropopliteal Stenosis

Keywords

Peripheral Artery Disease; Bioresorbable

Outcome Measures

Primary Outcomes (2)

• Major Adverse Event (MAE)

  30 days

• Freedom from Binary Restenosis

  12 months

Secondary Outcomes (14)

• Device Success

  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

Other Outcomes (5)

• 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

Study Arms (1)

EVSS

EXPERIMENTAL

Efemoral Vascular Scaffold System (EVSS)

Device: Efemoral Vascular Scaffold System (EVSS)

Interventions

Efemoral Vascular Scaffold System (EVSS) DEVICE

Balloon-expandable, bioresorbable vascular scaffolds coated with sirolimus

EVSS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Efemoral Medical, Inc.: lead

Study Sites (8)

Northern Health

Sydney, New South Wales, Australia

RECRUITING

Canberra Hospital

Canberra, Australia

RECRUITING

The Alfred Hospital

Melbourne, Australia

RECRUITING

Prince Of Wales Hospital

Sydney, Australia

RECRUITING

Royal North Shore

Sydney, Australia

RECRUITING

Auckland City Hospital

Auckland, 1142, New Zealand

RECRUITING

Christchurch Hospital

Christchurch, New Zealand

RECRUITING

Waikato Hospital

Hamilton, New Zealand

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Vascular Diseases; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lew Schwartz, MD

CONTACT

224-707-2601; lewis.schwartz@efemoralmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 14, 2020
• Study Start: September 22, 2020
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2030
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); NZ (3)