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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new stent, the ChampioNIR Stent System, designed to improve blood flow in people with blocked leg arteries (peripheral arterial disease). Participants will receive this stent in their leg artery and attend regular follow-ups to assess its effectiveness in keeping the artery open. The trial seeks individuals with significant leg artery blockages that cause pain or discomfort, limiting daily activities.

As an unphased trial, this study provides patients the opportunity to contribute to medical research and potentially benefit from an innovative treatment.

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 prior data suggests that the ChampioNIR Stent System is safe for treating leg artery stenosis?

Research shows that the ChampioNIR Drug Eluting Peripheral Stent is undergoing tests for safety in leg arteries. This stent releases ridaforolimus to the walls of blood vessels, potentially keeping them open and reducing blockages. Early studies examine patient tolerance and possible side effects. These studies aim to ensure that any side effects remain manageable.

As this is the first human trial of the stent, researchers closely monitor participants to gather detailed safety information. The trial's approval suggests that early data might indicate the stent's safety for human study. More information will emerge as the study progresses and more patients are observed over time. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for leg artery stenosis, which often involves bare-metal stents or drug-coated balloons, the ChampioNIR™ Ridaforolimus Eluting Peripheral Stent System offers a novel approach by delivering the drug ridaforolimus directly to the artery wall. This unique drug-eluting system not only supports the artery mechanically but also helps prevent re-narrowing by inhibiting cell growth at the site. Researchers are excited because this dual action could lead to better long-term outcomes, reducing the need for repeat procedures and improving overall blood flow in the legs.

What evidence suggests that the ChampioNIR Stent is effective for leg artery stenosis?

Research has shown that drug-eluting stents, such as the ChampioNIR Stent, hold promise for keeping leg arteries open. These stents slowly release medication to prevent the artery from narrowing again after treatment. In this trial, participants will receive the ChampioNIR Stent, designed for flexibility and durability, ensuring even medication distribution across the treated area. Although this stent is new and still under study, its design and drug delivery system build on successful features of other stents. Early research suggests it could effectively treat peripheral artery disease in the legs. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06410313

NCT06410313 | First In Human Study to Assess Safety and ... 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 ...

2. withpower.com withpower.com/trial/phase-constriction-pathologic-6-2024-c8484

ChampioNIR Stent for Leg Artery Stenosis (CHAMPIONSHIP Trial) The Eluvia drug-eluting vascular stent system has shown promising efficacy in maintaining patency of the femoropopliteal artery, making it a strong option for ...

3. ctv.veeva.com ctv.veeva.com/study/first-in-human-study-to-assess-safety-and-efficacy-of-the-championir-drug-eluting-peripheral-stent

First In Human Study to Assess Safety and Efficacy of the ... First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06410313/first-in-human-study-to-assess-safety-and-efficacy-of-the-championirtm-drug-eluting-peripheral-stent-in-the-treatment-of-patients-with-superficial-femoral-artery-disease-and-or-proximal-popliteal-artery-disease

First in Human Study to Assess Safety and Efficacy of the ... First in Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients with ...

5. medinol.com medinol.com/news/fda-approves-early-feasibility-study-for-our-groundbreaking-championir-drug-eluting-peripheral-stent-system/

FDA Approves Early Feasibility Study for our ... The ChampioNIR Drug-Eluting Peripheral Stent System combines a highly deliverable, and virtually un-fracturable stent that delivers drug to every millimeter ...