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No phaseActive, not 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 (CHAMPIONSHIP)

Sponsor
Medinol Ltd. (Industry)
Enrolment
30 planned
Conditions
Superficial Femoral Artery Stenosis; Popliteal Artery Stenosis
Interventions
ChampioNIR Ridaforolimus Eluting Peripheral Stent System
Ages
adults, older adults
Registry
NCT06410313

Full record on ClinicalTrials.gov

From the registry

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

Primary outcomes

  • Primary patency of the target lesion
  • Primary safety endpoint

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered