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
NCT ID: NCT06410313
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2024-08-15
2030-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Safety and Efficacy Study of the Dynalink®-E Everolimus Eluting Peripheral Stent System
NCT00475566
CVT-ISR First in Human Trial for Coronary In-Stent Restenosis
NCT05731700
Trial to Evaluate the Safety & Efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery
NCT01396525
IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial
NCT05971394
The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial
NCT00217256
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ChampioNIR™ Ridaforolimus Eluting Peripheral Stent System
ChampioNIR™ Ridaforolimus Eluting Peripheral Stent System
ChampioNIR Ridaforolimus Eluting Peripheral Stent System
ChampioNIR implantation in Patients with Superficial Femoral Artery Disease and/or Proximal Popliteal Artery disease
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ChampioNIR Ridaforolimus Eluting Peripheral Stent System
ChampioNIR implantation in Patients with Superficial Femoral Artery Disease and/or Proximal Popliteal Artery disease
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ankle-brachial index/toe-brachial index (ABI/TBI) \<0.90/0.80.
3. A single superficial femoral artery lesion with \>50% stenosis or total occlusion.
4. Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≤ 150 mm.
5. Reference vessel diameter (RVD) ≥ 3.0 mm and ≤ 5.0 mm by visual assessment.
6. Target lesion located with the distal point at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and proximal point at least 2 cm below the origin of the profunda femoris (deep femoral artery).
7. Patent infra-popliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (\<50% stenosis) to the ankle or foot.
8. The target lesion(s) can be successfully crossed with a guide wire and dilated.
9. The subject is eligible for standard surgical repair, if necessary.
10. Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent.
Exclusion Criteria
2. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
3. Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined \>50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoro-popliteal bypass graft and was not successfully treated prior to treatment of the target lesion either within the same procedure or at least 30 days prior to the index procedure.
4. Presence of residual ≥30% stenosis after either PTA or stenting of the inflow lesion.
5. Presence of an ipsilateral arterial artificial graft.
6. Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
7. Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
8. Required stent placement (in the target or any other lesion) via a retrograde approach.
9. Required stent placement (in the target or any other lesion) across or within 0.5 cm of the SFA / PFA bifurcation.
10. Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.
11. Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
12. Required stent placement within 1 cm of a previously (in a former procedure) deployed stent.
13. Use of atherectomy or other atheroablative (e.g. cryoplasty) devices at the time of index procedure.
14. Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.
15. Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
16. Overlapping stents are not allowed.
17. Coronary intervention within 7 days prior to or planned within 30 days after the treatment of the target lesion.
18. Stroke within the previous 30 days of the index procedure.
19. Known allergies to any of the following: aspirin, P2Y12 inhibitors (clopidogrel bisulfate, prasugrel, OR ticagrelor), heparin OR bivalirudin, nitinol (nickel titanium), PDLG, PLC, PDL, limus drugs (ridaforolimus, zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or any other analogue or derivative or similar compounds) or contrast agent, that cannot be medically managed.
20. Receiving dialysis or immunosuppressant therapy within the previous 30 days.
21. Known or suspected active systemic infection at the time of the procedure.
22. Known bleeding or hypercoagulability disorder or significant anemia (Hb\<8.0) that cannot be corrected.
23. Platelet count \<50,000/μL
24. International normalized ratio (INR) \> 1.5
25. GFR \<30 ml/min by Cockroft-Gault.
26. Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
27. Planned use of a drug coated balloon (DCB) during the index procedure.
28. Pregnant women or women of childbearing potential who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment.
29. Subject is participating in any investigational study that has not yet reached its primary endpoint
18 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medinol Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Piedmont Healthcare, Inc.
Atlanta, Georgia, United States
Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPH
New York, New York, United States
St Francis Hospital Heart Center
Roslyn, New York, United States
The Alfred Hospital
Melbourne, , Australia
Royal Perth Hospital
Perth, , Australia
Royal North Shore Hospital
Sydney, , Australia
Royal Prince Alfred Hospital
Sydney, , Australia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ChampioNIR DES-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.