ChampioNIR Stent for Leg Artery Stenosis

(CHAMPIONSHIP Trial)

Recruiting at 6 trial locations

Overseen By Brenda Koltun Reuven

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medinol Ltd.

Must not be taking: Aspirin, P2Y12 inhibitors

Disqualifiers: Dialysis, Infection, Anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

Duration: During the index procedure

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have known allergies to certain drugs like aspirin or P2Y12 inhibitors, or if you are on dialysis or immunosuppressant therapy, you may not be eligible to participate.

What data supports the effectiveness of the ChampioNIR Stent System for treating leg artery stenosis?

Research on similar drug-eluting stents, like the Eluvia stent, shows promising results in keeping leg arteries open and reducing the need for additional procedures. These stents release medication over time to prevent the artery from narrowing again, which suggests that the ChampioNIR Stent System might offer similar benefits. ^{1 2 3 4 5}

Is the ChampioNIR Stent generally safe for use in humans?

Research on paclitaxel-coated stents, like the ChampioNIR Stent, shows mixed safety results. Some studies found no increased risk of death, while others noted a higher risk of death over time compared to non-coated devices. It's important to discuss these findings with your doctor to understand what they mean for you. ^{1 6 7 8 9}

How is the ChampioNIR Stent treatment different from other treatments for leg artery stenosis?

The ChampioNIR Stent is unique because it is a drug-eluting stent, meaning it slowly releases medication to prevent the artery from narrowing again, which can reduce the need for additional procedures. This approach combines the mechanical support of a stent with the benefits of drug therapy, potentially offering better long-term results compared to traditional stents that do not release medication. ^{1 3 4 5 10}

Eligibility Criteria

This trial is for adults with narrowed or blocked arteries in the thigh or knee area, causing pain and limited mobility. Participants must have a specific range of artery size, one affected artery segment under 150 mm long that can be crossed and expanded with medical tools, and at least one open vessel below the blockage. They should be able to undergo surgery if needed.

Inclusion Criteria

My blood vessel size is between 3.0 mm and 5.0 mm.

I have leg pain from poor circulation that limits my activities, with specific test results.

I have a blocked artery in my leg.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients are treated with the ChampioNIR Stent System during the index procedure

During the index procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including patency evaluation by duplex ultrasound

36 months

Follow-up visits at 30 days, 6, 12, 24, and 36 months

Treatment Details

Interventions

• ChampioNIR™ Drug Eluting Peripheral Stent

Trial Overview The study tests the ChampioNIR Stent System designed to prop open arteries in the leg (specifically femoral or popliteal) after they've been unblocked. It's an initial test on humans to see how safe it is and how well it works over time, with follow-ups up to three years post-procedure.

Participant Groups

Group I: ChampioNIR™ Ridaforolimus Eluting Peripheral Stent System Experimental Treatment 1 Intervention

ChampioNIR™ Ridaforolimus Eluting Peripheral Stent System

ChampioNIR™ Drug Eluting Peripheral Stent is already approved in United States for the following indications:

Approved in United States as ChampioNIR Drug Eluting Peripheral Stent System for:

• Superficial Femoral Artery Disease
• Proximal Popliteal Artery Disease

Who Is Running the Clinical Trial?

Medinol Ltd.

Lead Sponsor

Trials

16

Recruited

3,400+

Findings from Research

The Supera Peripheral Stent System® demonstrated good long-term safety and efficacy in treating severe femoropopliteal lesions, with primary patency rates of 72.6% at 12 months and 60.8% at 24 months in a study of 136 limbs from 128 patients.

The stent showed acceptable freedom from target lesion revascularization (TLR) rates of 73.8% at 12 months and 62.8% at 24 months, indicating its effectiveness even in complex cases with extensive calcification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-expanding interwoven nitinol stent in severe femoropopliteal arterial disease. Real life results of the Supera Peripheral Stent System®. Van Meirvenne, E., Reyntjens, P., Tielemans, Y.[2023]

The Solitaire™ AB Stent System (PMT) demonstrated significantly better outcomes than conventional catheter-directed thrombolytic therapy (CDT) for treating acute lower extremity ischemia, with a lower composite clinical outcome rate (9.1% vs. 26.4%) and reduced mortality (7.3% vs. 19.8%) over 12 months.

Patients treated with PMT required a lower dose of thrombolytic drugs and had shorter hospital stays compared to those receiving CDT, indicating that PMT is not only safer but also more efficient in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Solitaire™ Stent Thrombectomy System in the Treatment of Acute Lower-Limb Ischemia: Comparisons in Safety and Effectiveness with Conventional Catheter-Directed Thrombolysis Therapy. Huang, H., Gu, J., Su, H., et al.[2023]

The Eluvia Drug-Eluting Vascular Stent System showed a high primary patency rate of 83.5% at 2 years and 85.3% freedom from target lesion revascularization (TLR) at 3 years in a study of 57 patients with symptomatic lower limb ischemia.

No stent fractures or major limb amputations occurred during the 3-year follow-up, indicating a strong safety profile for the Eluvia stent in treating femoropopliteal artery lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Results from the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Femoropopliteal Treatment: 3-Year Follow-up. Müller-Hülsbeck, S., Keirse, K., Zeller, T., et al.[2018]

The Eluvia drug-eluting vascular stent system has shown promising efficacy in maintaining patency of the femoropopliteal artery, making it a strong option for treating lower extremity peripheral arterial disease.

Initial clinical results indicate that the Eluvia stent has a good safety profile, suggesting it is a reliable choice for patients who do not respond adequately to noninvasive therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eluvia drug-eluting vascular stent system for the treatment of symptomatic femoropopliteal lesions. Müller-Hülsbeck, S., Hopf-Jensen, S., Keirse, K., et al.[2019]

In the MAJESTIC study involving 57 patients with chronic lower limb ischemia, the Eluvia paclitaxel-eluting stent demonstrated a high primary patency rate of 96% at 12 months, indicating its effectiveness in treating femoropopliteal lesions.

The study reported a low major adverse event (MAE) rate of 4%, with no major amputations and only one unrelated death, highlighting the safety of the Eluvia stent in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. Müller-Hülsbeck, S., Keirse, K., Zeller, T., et al.[2018]

Paclitaxel drug-coated balloons and drug-eluting stents, introduced for treating intermittent claudication, showed better limb revascularization compared to non-coated devices, but recent studies raised concerns about a potential increase in late all-cause mortality associated with these treatments.

In response to these safety concerns, a Vascular Leaders Forum was convened with 100 experts from various fields to investigate the findings and discuss the implications for patient care, aiming to balance the risks and benefits of these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel-Coated Balloons and Eluting Stents: Is There a Mortality Risk in Patients With Peripheral Artery Disease? Beckman, JA., White, CJ.[2020]

A systematic review of 28 randomized controlled trials involving 4663 patients found that while paclitaxel-coated devices did not increase the risk of death at 1 year, there was a significant increase in all-cause mortality at 2 years (7.2% vs. 3.8%) and at 5 years (14.7% vs. 8.1%) compared to control groups.

The analysis revealed a dose-dependent relationship between paclitaxel exposure and the risk of death, indicating that higher doses over time are associated with increased mortality, highlighting the need for further investigation into the safety of these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Katsanos, K., Spiliopoulos, S., Kitrou, P., et al.[2023]

The IN.PACT SFA trial, involving 331 patients with femoropopliteal peripheral artery disease, found that the IN.PACT Admiral drug-coated balloon (DCB) angioplasty significantly improved long-term outcomes, with 74.5% of patients free from clinically driven target lesion revascularization after 5 years compared to 65.3% for standard angioplasty (PTA).

The DCB also demonstrated a favorable safety profile, with no device-related deaths and a primary safety composite achieved in 70.7% of DCB patients versus 59.6% in the PTA group, supporting its use as a preferred treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. Laird, JA., Schneider, PA., Jaff, MR., et al.[2022]

In a study of 10,505 patients with peripheral artery disease treated with either paclitaxel-coated devices (PCDs) or non-PCDs, there was no significant difference in long-term survival rates, indicating that PCDs do not increase the risk of all-cause mortality.

The causes of death were similar between patients treated with PCDs and those with non-PCDs, suggesting that the use of paclitaxel-coated devices is safe in terms of long-term mortality outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival and Causes of Death Among Veterans With Lower Extremity Revascularization With Paclitaxel-Coated Devices: Insights From the Veterans Health Administration. Gutierrez, JA., Rao, SV., Jones, WS., et al.[2021]

The Supera peripheral stent system, made from a braided nickel-titanium alloy, is designed to endure the high biomechanical stress of the femoropopliteal artery, potentially leading to improved long-term patency and reduced stent fracture rates.

There is a critical need for further research, including randomized controlled trials, to compare the effectiveness of the Supera stent against other stent platforms and angioplasty alone in treating femoropopliteal lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supera self-expanding stents for endovascular treatment of femoropopliteal disease: a review of the clinical evidence. Bishu, K., Armstrong, EJ.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Self-expanding interwoven nitinol stent in severe femoropopliteal arterial disease. Real life results of the Supera Peripheral Stent System®. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Solitaire™ Stent Thrombectomy System in the Treatment of Acute Lower-Limb Ischemia: Comparisons in Safety and Effectiveness with Conventional Catheter-Directed Thrombolysis Therapy. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Long-Term Results from the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Femoropopliteal Treatment: 3-Year Follow-up. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Eluvia drug-eluting vascular stent system for the treatment of symptomatic femoropopliteal lesions. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Paclitaxel-Coated Balloons and Eluting Stents: Is There a Mortality Risk in Patients With Peripheral Artery Disease? [2020]

7. England pubmed.ncbi.nlm.nih.gov

Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Survival and Causes of Death Among Veterans With Lower Extremity Revascularization With Paclitaxel-Coated Devices: Insights From the Veterans Health Administration. [2021]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Supera self-expanding stents for endovascular treatment of femoropopliteal disease: a review of the clinical evidence. [2018]