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RECRUITING NA

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

NCT06410313 · View on ClinicalTrials.gov ↗

Study 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

Interventions

  • DEVICE ChampioNIR Ridaforolimus Eluting Peripheral Stent System

Study Locations (7)

Other

  • The Alfred Hospital — Melbourne
  • Royal Perth Hospital — Perth
  • Royal North Shore Hospital — Sydney
  • Royal Prince Alfred Hospital — Sydney

New York

  • Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPH — New York
  • St Francis Hospital Heart Center — Roslyn

Georgia

  • Piedmont Healthcare, Inc. — Atlanta

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2024-08-15
Est. Completion 2030-02-28
Phase NA

Sponsor

Medinol

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06410313

The ClinicalTrials.gov registry entry for NCT06410313 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medinol, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Superficial Femoral Artery Stenosis appearing as the primary indexed condition, and to 1 intervention — of which ChampioNIR Ridaforolimus Eluting Peripheral Stent System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06410313 reports 7 study locations spanning 3 distinct geographic areas — top geographies include Other, New York, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06410313 about?

NCT06410313 is a clinical study titled "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". 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 ...

What is the current status of trial NCT06410313?

This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2024-08-15. Estimated completion is 2030-02-28.

What conditions does trial NCT06410313 study?

This clinical trial studies the following conditions: Superficial Femoral Artery Stenosis, Popliteal Artery Stenosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06410313?

The interventions under investigation include: ChampioNIR Ridaforolimus Eluting Peripheral Stent System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06410313?

This trial is sponsored by Medinol, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06410313 being conducted?

This trial has 7 study locations across Georgia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial