Actively Recruiting
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
Led by Medinol Ltd. · Updated on 2025-09-22
30
Participants Needed
7
Research Sites
289 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with legal consent.
- Lifestyle limiting claudication or rest pain classified as Rutherford-Becker scale 2-4 with resting ABI/TBI less than 0.90/0.80.
- Single superficial femoral artery lesion with greater than 50% narrowing or total blockage.
- Stenotic or occluded lesion length within the same vessel of 150 mm or less.
- Reference vessel diameter between 3.0 mm and 5.0 mm.
- Target lesion located at least 3 cm above the knee joint and at least 2 cm below the origin of the profunda femoris artery.
- Patent infra-popliteal and popliteal artery with at least one vessel having less than 50% narrowing to the ankle or foot.
- Target lesion can be crossed with a guide wire and dilated.
- Eligible for standard surgical repair if needed.
- Willing and able to comply with scheduled visits and provide informed consent.
You will not qualify if you...
- Presence of thrombus in the treated vessel before crossing the lesion.
- Thrombolysis on the target vessel within 72 hours prior to the procedure without complete thrombus resolution.
- Poor inflow due to more than 50% narrowing of iliac or common femoral artery not successfully treated prior to target lesion treatment.
- Residual 30% or greater narrowing after PTA or stenting of inflow lesion.
- Presence of an ipsilateral arterial artificial graft.
- Ipsilateral femoral aneurysm or aneurysm in the superficial femoral or popliteal artery.
- Lesions in contralateral superficial femoral or proximal popliteal artery requiring intervention during or within 30 days of the procedure.
- Required stent placement via a retrograde approach.
- Stent placement across or within 0.5 cm of the superficial femoral artery/profunda femoris artery bifurcation.
- Procedures requiring stent-in-stent placement.
- Significant vessel tortuosity or 90° bend preventing stent delivery.
- Stent placement within 1 cm of a previously deployed stent.
- Use of atherectomy or other atheroablative devices during the procedure.
- Restenotic lesion treated by atherectomy, laser, or cryoplasty within 3 months.
- Tissue loss classified as Rutherford-Becker category 5 or 6.
- Overlapping stents not allowed.
- Coronary intervention within 7 days before or planned within 30 days after target lesion treatment.
- Stroke within 30 days before the procedure.
- Allergies to aspirin, P2Y12 inhibitors, heparin or bivalirudin, nitinol, drug coatings, or contrast agents not medically manageable.
- Receiving dialysis or immunosuppressants within 30 days.
- Active systemic infection at procedure time.
- Bleeding or clotting disorders or significant anemia not correctable.
- Platelet count below 50,000/μL.
- INR greater than 1.5.
- GFR below 30 ml/min.
- Co-morbid illness with life expectancy less than 1 year.
- Planned use of drug-coated balloon during procedure.
- Pregnant women or women of childbearing potential without a recent negative pregnancy test.
- Participation in another investigational study not yet at primary endpoint.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Piedmont Healthcare, Inc.
Atlanta, Georgia, United States, 30318
Not Yet Recruiting
2
Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPH
New York, New York, United States, 10032
Not Yet Recruiting
3
St Francis Hospital Heart Center
Roslyn, New York, United States, 11576
Not Yet Recruiting
4
The Alfred Hospital
Melbourne, Australia
Actively Recruiting
5
Royal Perth Hospital
Perth, Australia
Not Yet Recruiting
6
Royal North Shore Hospital
Sydney, Australia
Actively Recruiting
7
Royal Prince Alfred Hospital
Sydney, Australia
Actively Recruiting
Research Team
B
Brenda Koltun Reuven
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here