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

NCT06410313 | Recruiting DMC FDA Device

• 1 other identifier: ChampioNIR DES-001
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 7

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

Conditions

Superficial Femoral Artery Stenosis; Popliteal Artery Stenosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Primary patency

  30 days and 12 months

• Acute device success

  During the index procedure

• Acute procedural success

  During the index procedure

• Acute technical success

  During the index procedure

• Secondary Patency

  30 days 6, 12, 24 and 36 months

Study Arms (1)

ChampioNIR™ Ridaforolimus Eluting Peripheral Stent System

EXPERIMENTAL

ChampioNIR™ Ridaforolimus Eluting Peripheral Stent System

Device: ChampioNIR Ridaforolimus Eluting Peripheral Stent System

Interventions

ChampioNIR Ridaforolimus Eluting Peripheral Stent System DEVICE

ChampioNIR implantation in Patients with Superficial Femoral Artery Disease and/or Proximal Popliteal Artery disease

ChampioNIR™ Ridaforolimus Eluting Peripheral Stent System

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and of age of legal consent.
• 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.
• A single superficial femoral artery lesion with \>50% stenosis or total occlusion.
• Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≤ 150 mm.
• Reference vessel diameter (RVD) ≥ 3.0 mm and ≤ 5.0 mm by visual assessment.
• 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).
• 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.
• The target lesion(s) can be successfully crossed with a guide wire and dilated.
• The subject is eligible for standard surgical repair, if necessary.
• Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent.

You may not qualify if:

• Presence of thrombus in the treated vessel as visualized by angiography, prior to crossing the lesion.
• Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
• 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.
• Presence of residual ≥30% stenosis after either PTA or stenting of the inflow lesion.
• Presence of an ipsilateral arterial artificial graft.
• Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
• Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
• Required stent placement (in the target or any other lesion) via a retrograde approach.
• Required stent placement (in the target or any other lesion) across or within 0.5 cm of the SFA / PFA bifurcation.
• Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.
• Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
• Required stent placement within 1 cm of a previously (in a former procedure) deployed stent.
• Use of atherectomy or other atheroablative (e.g. cryoplasty) devices at the time of index procedure.
• Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.
• Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.

Sponsors & Collaborators

• Medinol Ltd.: lead

Study Sites (7)

Piedmont Healthcare, Inc.

Atlanta, Georgia, 30318, United States

NOT YET RECRUITING

Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPH

New York, New York, 10032, United States

NOT YET RECRUITING

St Francis Hospital Heart Center

Roslyn, New York, 11576, United States

NOT YET RECRUITING

The Alfred Hospital

Melbourne, Australia

RECRUITING

Royal Perth Hospital

Perth, Australia

NOT YET RECRUITING

Royal North Shore Hospital

Sydney, Australia

RECRUITING

Royal Prince Alfred Hospital

Sydney, Australia

RECRUITING

Central Study Contacts

Brenda Koltun Reuven

CONTACT

719-331-1638; brendak@medinol.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 13, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): February 28, 2030
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); AU (4)