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

ConditionsPeripheral Arterial Disease Vascular Diseases Stenosis Femoropopliteal Stenosis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorEfemoral Medical, Inc.

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

Efemoral Vascular Scaffold System (EVSS)

Treatment groups

100 Participants

are divided into 1 treatment group

Sponsors and collaborators

Efemoral Medical, Inc.

Lead sponsor

Source ClinicalTrials.gov