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

NCT ID: NCT04584632

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-22
• Study Completion Date: 2028-03-31

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.

Conditions

Peripheral Arterial Disease; Vascular Diseases; Stenosis; Femoropopliteal Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EVSS

Efemoral Vascular Scaffold System (EVSS)

Group Type: EXPERIMENTAL

Efemoral Vascular Scaffold System (EVSS)

Intervention Type: DEVICE

Balloon-expandable, bioresorbable vascular scaffolds coated with sirolimus

Interventions

Efemoral Vascular Scaffold System (EVSS)

Balloon-expandable, bioresorbable vascular scaffolds coated with sirolimus

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Efemoral Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Prince Of Wales Hospital

Sydney, , Australia

Site Status: RECRUITING

Auckland City Hospital

Auckland, , New Zealand

Site Status: RECRUITING

Christchurch Hospital

Christchurch, , New Zealand

Site Status: RECRUITING

Waikato Hospital

Hamilton, , New Zealand

Site Status: RECRUITING

Countries

Australia; New Zealand

Central Contacts

Lew Schwartz, MD

Role: CONTACT

lewis.schwartz@efemoralmedical.com

224-707-2601

Facility Contacts

Ramon Varcoe, MD

Role: primary

Andrew Holden, MD

Role: primary

andrewh@adhb.govt.nz

6493670000

Ruth Benson, MD

Role: primary

Manar Khashram, MD

Role: primary

Other Identifiers

CL05122020

Identifier Type: -

Identifier Source: org_study_id