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Study identifier: NCT06410313 Synced from ClinicalTrials.gov · July 28, 2026
● 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

Condition: Superficial Femoral Artery Stenosis · Popliteal Artery Stenosis  ·  Sponsor: Medinol Ltd.

PhaseNA
Planned participants30
Who can joinAll sexes, 18 Years to 120 Years
Healthy volunteersNo

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

Brenda Koltun Reuven  ·  719-331-1638  ·  brendak@medinol.com

Always discuss trial participation with your own doctor first.

Locations (7)

Piedmont Healthcare, Inc.Atlanta, Georgia, United StatesNot Yet Recruiting
Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPHNew York, New York, United StatesNot Yet Recruiting
St Francis Hospital Heart CenterRoslyn, New York, United StatesNot Yet Recruiting
The Alfred HospitalMelbourne, AustraliaRecruiting
Royal Perth HospitalPerth, AustraliaNot Yet Recruiting
Royal North Shore HospitalSydney, AustraliaRecruiting
Royal Prince Alfred HospitalSydney, AustraliaRecruiting

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Source record: clinicaltrials.gov/study/NCT06410313