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NCT06410313 · ClinicalTrials.gov registry record · 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
A NA study of Superficial Femoral Artery Stenosis and Popliteal Artery Stenosis, sponsored by Medinol.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 7
- Study locations
NCT06410313 is a NA study of Superficial Femoral Artery Stenosis and Popliteal Artery Stenosis that is actively recruiting participants, run by Medinol. The registered enrollment target is 30 participants. The trial reports 7 study locations across 3 states.
The verdict
NCT06410313, a NA study of Superficial Femoral Artery Stenosis and Popliteal Artery Stenosis, is actively recruiting participants, sponsored by Medinol.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 7
- Study locations
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-08-15 |
| Est. Completion | 2030-02-28 |
| Phase | NA |
Interested in This Trial?
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, categorized as NA. 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 4 total studies on file at ClinicalTrials.gov.
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.
NCT06410313 reports 7 study locations spanning 3 distinct geographic areas - top geographies include Other, New York, Georgia.
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.
What interventions are being tested in trial NCT06410313?
The interventions under investigation include: ChampioNIR Ridaforolimus Eluting Peripheral Stent System (DEVICE).
Who is sponsoring clinical trial NCT06410313?
This trial is sponsored by Medinol, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
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