Status: Recruiting
First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease
This is a prospective, open label, multicenter, single arm, first in human clinical study. Patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be enrolled. The patients will be treated with the ChampioNIR Stent System. All implanted patients will be followed up at 30 days and 6, 12, 24 and 36 months. The follow-up visits will include patency evaluation by duplex ultrasound
Participants needed: 30
Trial details
Age: 18-120Biological sex: AllType: InterventionalSponsor: Medinol Ltd.Updated: Sep 22, 2025Locations: 7
Eligibility criteria
Age ≥ 18 years and of age of legal consent. [+9]
Presence of thrombus in the treated vessel as visualized by angiography, prior t... [+28]