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)

Efemoral Medical

Status

Enrolling

Conditions

Femoropopliteal Stenosis

Vascular Diseases

Peripheral Arterial Disease

Stenosis

Treatments

Device: Efemoral Vascular Scaffold System (EVSS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04584632

CL05122020

Details and patient eligibility

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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