Clinical trial NCT06410313: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Superficial Femoral Artery Stenosis
Popliteal Artery Stenosis
Lead sponsor: Medinol Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years and of age of legal consent.
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:

1. Presence of thrombus in the treated vessel as visualized by angiography, prior to crossing the lesion.
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

Primary outcomes:
measure: Primary patency of the target lesion
timeFrame: 6 months
measure: Primary safety endpoint
timeFrame: 30 days
Secondary outcomes:
measure: Primary patency
timeFrame: 30 days and 12 months
measure: Acute device success
timeFrame: During the index procedure
measure: Acute procedural success
timeFrame: During the index procedure
measure: Acute technical success
timeFrame: During the index procedure
measure: Secondary Patency
timeFrame: 30 days 6, 12, 24 and 36 months
measure: Change of Rutherford classification
timeFrame: 30 days 6, 12, 24 and 36 months
measure: Change of resting ankle-brachial index (ABI)
timeFrame: 30 days 6, 12, 24 and 36 months
measure: Change in walking impairment questionnaire
timeFrame: 30 days 6, 12, 24 and 36 months
measure: Combined rate of the following events: death at 30 days, target vessel revascularization (TVR), index limb amputation and increase in Rutherford-Becker Classification by ≥2 classes (as compared to post-procedural assessment)
timeFrame: 12 months
measure: Stent fracture
timeFrame: 12 and 36 months
measure: Freedom from all-cause death, index limb amputation above the ankle and Target Vessel Revascularization
timeFrame: 30 days
measure: All-cause death
timeFrame: 30 days, 6, 12, 24 and 36 months
measure: Amputation (above the ankle)-Free Survival (AFS)
timeFrame: 30 days, 6, 12, 24 and 36 months
measure: Target Vessel Revascularization (TVR)
timeFrame: 30 days, 6, 12, 24 and 36 months
measure: Target Lesion Revascularization (TLR)
timeFrame: 30 days, 6, 12, 24 and 36 months
measure: Rate of Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature
timeFrame: 30 days, 6, 12, 24 and 36 months
measure: Major Adverse Limb Events (MALE)
timeFrame: 30 days, 6, 12, 24 and 36 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Healthcare, Inc.
state: Georgia
city: New York
country: United States
facility: Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPH
state: New York
city: Roslyn
country: United States
facility: St Francis Hospital Heart Center
state: New York
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Perth
country: Australia
facility: Royal Perth Hospital
city: Sydney
country: Australia
facility: Royal North Shore Hospital
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
Study officials:
References: