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

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 15, 2024

Primary Completion Date

January 30, 2027

Study Completion Date

February 28, 2030

Conditions
Superficial Femoral Artery StenosisPopliteal Artery Stenosis
Interventions
DEVICE

ChampioNIR Ridaforolimus Eluting Peripheral Stent System

ChampioNIR implantation in Patients with Superficial Femoral Artery Disease and/or Proximal Popliteal Artery disease

Trial Locations (7)

10032

NOT_YET_RECRUITING

Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPH, New York

11576

NOT_YET_RECRUITING

St Francis Hospital Heart Center, Roslyn

30318

NOT_YET_RECRUITING

Piedmont Healthcare, Inc., Atlanta

Unknown

RECRUITING

The Alfred Hospital, Melbourne

NOT_YET_RECRUITING

Royal Perth Hospital, Perth

RECRUITING

Royal North Shore Hospital, Sydney

RECRUITING

Royal Prince Alfred Hospital, Sydney

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medinol Ltd.

INDUSTRY

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 | Biotech Hunter | Biotech Hunter