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

ClinicalTrials.gov ID: NCT06410313

Public ClinicalTrials.gov record NCT06410313. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 19, 2026, 4:23 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT06410313
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: Medinol Ltd.; Industry
Enrollment: 30 participants

Conditions and interventions

Conditions

Interventions

ChampioNIR Ridaforolimus Eluting Peripheral Stent System Device

Device

Eligibility (public fields only)

Age range: 18 Years to 120 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 15, 2024 (Actual)
Primary completion: Jan 30, 2027 (Estimated)
Completion: Feb 28, 2030 (Estimated)
Last update posted: Oct 9, 2026

2024 – 2030

United States locations

U.S. sites: 3
U.S. states: 2
U.S. cities: 3

Facility	City	State	ZIP	Site status
Piedmont Healthcare, Inc.	Atlanta	Georgia	30318	—
Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPH	New York	New York	10032	—
St Francis Hospital Heart Center	Roslyn	New York	11576	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06410313, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 9, 2026 · Synced Oct 19, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06410313 live on ClinicalTrials.gov.

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