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 (CHAMPIONSHIP)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Popliteal Artery Stenosis; Superficial Femoral Artery Stenosis
• Intervention / Treatment: Device: ChampioNIR Ridaforolimus Eluting Peripheral Stent System

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brenda Koltun Reuven; Phone Number: +972542666688; Email: brendak@medinol.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ChampioNIR™ Ridaforolimus Eluting Peripheral Stent System	Device: ChampioNIR Ridaforolimus Eluting Peripheral Stent System; ChampioNIR implantation in Patients with Superficial Femoral Artery Disease and/or Proximal Popliteal Artery disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency of the target lesion	Primary patency of the target lesion defined as the absence of target lesion restenosis (defined by Duplex ultrasound (US) peak systolic velocity ratio (PSVR) ≥2.4).	6 months
Primary safety endpoint	Composite rate of freedom from all-cause death, target vessel revascularization or any amputation of the index limb through 30 days following stent implantation	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency	Primary patency defined by Duplex US peak systolic velocity ratio (absence of restenosis which defined by Duplex US PSVR ≥2.4)	30 days and 12 months
Acute device success	Acute device success, defined as achievement of a final residual diameter stenosis of <30% by Quantitative Angiography (QA), using the assigned treatment only	During the index procedure
Acute procedural success	Acute procedural success, defined as device success with <30% residual stenosis immediately after stent placement or mean trans-stenotic pressure gradient <5 mmHg, and without the occurrence of death, amputation or repeat revascularization of the target lesion during the hospital stay	During the index procedure
Acute technical success	Acute technical success, defined as the attainment of <30% residual stenosis by QA by any percutaneous method as determined by the angiographic core laboratory	During the index procedure
Secondary Patency	Secondary Patency (absence of restenosis which is defined as Duplex US PSVR ≥ 2.4)	30 days 6, 12, 24 and 36 months
Change of Rutherford classification	Change of Rutherford classification from baseline	30 days 6, 12, 24 and 36 months
Change of resting ankle-brachial index (ABI)	Change of resting ankle-brachial index (ABI) from baseline	30 days 6, 12, 24 and 36 months
Change in walking impairment questionnaire	Change in walking impairment questionnaire from baseline	30 days 6, 12, 24 and 36 months
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)	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)	12 months
Stent fracture	Evidence of Stent fracture analyzed by a two-view X-ray evaluation	12 and 36 months
Freedom from all-cause death, index limb amputation above the ankle and Target Vessel Revascularization	Freedom from all-cause death, index limb amputation above the ankle and Target Vessel Revascularization	30 days
All-cause death	All-cause death	30 days, 6, 12, 24 and 36 months
Amputation (above the ankle)-Free Survival (AFS)	Amputation (above the ankle)-Free Survival (AFS)	30 days, 6, 12, 24 and 36 months
Target Vessel Revascularization (TVR)	Target Vessel Revascularization (TVR)	30 days, 6, 12, 24 and 36 months
Target Lesion Revascularization (TLR)	Target Lesion Revascularization (TLR)	30 days, 6, 12, 24 and 36 months
Rate of Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature	Rate of Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature	30 days, 6, 12, 24 and 36 months
Major Adverse Limb Events (MALE)	Stent thrombosis, Clinically apparent distal embolization, Procedure-related arterial rupture, Acute limb ischemia, Target limb amputation, Procedure related bleeding event requiring transfusion	30 days, 6, 12, 24 and 36 months

Collaborators and Investigators

• Sponsor: Medinol Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2024
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: ChampioNIR DES-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes