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Superficial Femoral Artery StenosisCHAMPIONSHIPNCT06410313

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

A study testing ChampioNIR Ridaforolimus Eluting Peripheral Stent System in people with Superficial Femoral Artery Stenosis and Popliteal Artery Stenosis, run by Medinol Ltd. at 7 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
ChampioNIR Ridaforolimus Eluting Peripheral Stent System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
7 sitesin 2 countries
Study dates
15 Aug 2024to 28 Feb 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 29Show fewer
  • 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.
  • Overlapping stents are not allowed.
  • Coronary intervention within 7 days prior to or planned within 30 days after the treatment of the target lesion.
  • Stroke within the previous 30 days of the index procedure.
  • 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.
  • Receiving dialysis or immunosuppressant therapy within the previous 30 days.
  • Known or suspected active systemic infection at the time of the procedure.
  • Known bleeding or hypercoagulability disorder or significant anemia (Hb<8.0) that cannot be corrected.
  • Platelet count <50,000/μL
  • International normalized ratio (INR) > 1.5
  • GFR <30 ml/min by Cockroft-Gault.
  • Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
  • Planned use of a drug coated balloon (DCB) during the index procedure.
  • 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.
  • Subject is participating in any investigational study that has not yet reached its primary endpoint

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Australia4 sites

  • The Alfred Hospital

    Melbourne

  • Royal Perth Hospital

    Perth

  • Royal North Shore Hospital

    Sydney

  • Royal Prince Alfred Hospital

    Sydney

Other trials in Australia

United States3 sites

  • Piedmont Healthcare, Inc.

    Atlanta, Georgia, 30318

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

    New York, New York, 10032

  • St Francis Hospital Heart Center

    Roslyn, New York, 11576

Other trials in United States

About this study

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

Being tested
ChampioNIR Ridaforolimus Eluting Peripheral Stent System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChampioNIR Ridaforolimus Eluting Peripheral Stent SystemDevice

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

Study groups in NCT06410313
Study groupRoleWhat they receive
ChampioNIR™ Ridaforolimus Eluting Peripheral Stent SystemExperimentalChampioNIR™ Ridaforolimus Eluting Peripheral Stent System
Receives: Device: ChampioNIR Ridaforolimus Eluting Peripheral Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6 months

  2. 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

    Measured: 30 days

Secondary outcomes (17)

  1. Primary patency

    Primary patency defined by Duplex US peak systolic velocity ratio (absence of restenosis which defined by Duplex US PSVR ≥2.4)

    Measured: 30 days and 12 months

  2. 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

    Measured: During the index procedure

  3. 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

    Measured: During the index procedure

  4. 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

    Measured: During the index procedure

  5. Secondary Patency

    Secondary Patency (absence of restenosis which is defined as Duplex US PSVR ≥ 2.4)

    Measured: 30 days 6, 12, 24 and 36 months

  6. Change of Rutherford classification

    Change of Rutherford classification from baseline

    Measured: 30 days 6, 12, 24 and 36 months

  7. Change of resting ankle-brachial index (ABI)

    Change of resting ankle-brachial index (ABI) from baseline

    Measured: 30 days 6, 12, 24 and 36 months

  8. Change in walking impairment questionnaire

    Change in walking impairment questionnaire from baseline

    Measured: 30 days 6, 12, 24 and 36 months

  9. 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)

    Measured: 12 months

  10. Stent fracture

    Evidence of Stent fracture analyzed by a two-view X-ray evaluation

    Measured: 12 and 36 months

  11. 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

    Measured: 30 days

  12. All-cause death

    All-cause death

    Measured: 30 days, 6, 12, 24 and 36 months

  13. Amputation (above the ankle)-Free Survival (AFS)

    Amputation (above the ankle)-Free Survival (AFS)

    Measured: 30 days, 6, 12, 24 and 36 months

  14. Target Vessel Revascularization (TVR)

    Target Vessel Revascularization (TVR)

    Measured: 30 days, 6, 12, 24 and 36 months

  15. Target Lesion Revascularization (TLR)

    Target Lesion Revascularization (TLR)

    Measured: 30 days, 6, 12, 24 and 36 months

  16. 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

    Measured: 30 days, 6, 12, 24 and 36 months

  17. 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

    Measured: 30 days, 6, 12, 24 and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2024
  2. Study start15 Aug 2024
  3. Primary completion30 Jan 2027 (estimated)
  4. Study completion28 Feb 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06410313
Sponsor's protocol ID
ChampioNIR DES-001
Acronym
CHAMPIONSHIP
Status last verified
Oct 2026
First submitted
1 May 2024
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ChampioNIR Ridaforolimus Eluting Peripheral Stent System in people with Superficial Femoral Artery Stenosis and Popliteal Artery Stenosis, run by Medinol Ltd. at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary patency of the target lesion (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06410313.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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