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
Medinol Ltd.
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
Eligibility
- Age range
- 18–120 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years and of age of legal consent. 2. Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ankle-brachial index/toe-brachial index (ABI/TBI) \<0.90/0.80. 3. A single superficial femoral artery lesion with \>50% stenosis or total occlusion. 4. Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≤ 150 mm. 5. Reference vessel diameter (RVD) ≥ 3.0 mm and ≤ 5.0 mm by visual assessment. 6. Target lesion located with the distal point at least 3 cm above the knee joint, defi…
Interventions
- DeviceChampioNIR Ridaforolimus Eluting Peripheral Stent System
ChampioNIR implantation in Patients with Superficial Femoral Artery Disease and/or Proximal Popliteal Artery disease
Locations (7)
- Piedmont Healthcare, Inc.Atlanta, Georgia
- Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPHNew York, New York
- St Francis Hospital Heart CenterRoslyn, New York
- The Alfred HospitalMelbourne
- Royal Perth HospitalPerth
- Royal North Shore HospitalSydney