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

Conditions

• Popliteal Artery Stenosis
• Superficial Femoral Artery Stenosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

Start date

Aug 15, 2024

Status verified

Sep 2025

Primary completion

Jan 30, 2027

Completion

Feb 28, 2030

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: ChampioNIR™ Ridaforolimus Eluting Peripheral Stent System
  ChampioNIR™ Ridaforolimus Eluting Peripheral Stent System

Primary Outcome Measure

Primary patency of the target lesion [ Time Frame: 6 months ]

Central Contacts

• Brenda Koltun Reuven
  719-331-1638
  [email protected]

Locations (3)

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