NCT06410313

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Medinol Ltd. · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Superficial Femoral Artery Stenosis
• Popliteal Artery Stenosis

Interventions

Type	Name	Description
DEVICE	ChampioNIR Ridaforolimus Eluting Peripheral Stent System	ChampioNIR implantation in Patients with Superficial Femoral Artery Disease and/or Proximal Popliteal Artery disease

Timeline

• Start date: 2024-08-15
• Primary completion: 2027-01-30
• Completion: 2030-02-28
• First posted: 2024-05-13
• Last updated: 2025-09-22

Locations

7 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated device study