Drug-Coated Balloon Angioplasty for Peripheral Arterial Disease

Not currently recruiting at 52 trial locations

Overseen By Ravi Ramana, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.A. Med Alliance S.A.

Must not be taking: Limus family, CYP3A4 inhibitors, CYP3A4 inducers

Disqualifiers: Stroke, MI, Renal insufficiency, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: Immediate procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist individuals with peripheral arterial disease (PAD), a condition where leg arteries narrow or block, causing walking pain. The treatment uses a drug-coated balloon (SELUTION SLR™ 018 DEB) to open blocked arteries and deliver medication directly to the site, potentially keeping them open longer than a plain balloon. Individuals with PAD in the leg's superficial femoral artery or proximal popliteal artery who can walk without a walker might qualify for this study. Participants will receive either the drug-coated balloon treatment or standard balloon angioplasty to compare results. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for PAD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain medications like strong CYP3A4 inhibitors or inducers within 14 days before the procedure or plan to take them during the study. It's best to discuss your current medications with the study team.

What prior data suggests that the SELUTION SLR™ 018 DEB is safe for treating peripheral arterial disease?

Research has shown that the SELUTION SLR™ 018 DEB has undergone thorough safety testing for treating peripheral artery disease (PAD). Studies have demonstrated that this drug-coated balloon is effective and safe for complex PAD cases. These studies included real-world patients, meaning the treatment was tested in everyday settings, not just controlled labs.

The SELUTION SLR™ 018 DEB releases sirolimus over 90 days to help prevent arteries from narrowing again. Long-term data, up to 36 months, confirmed its safety, with no reports of unexpected safety issues. These findings suggest that the treatment is generally well-tolerated, offering reassurance to those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard uncoated balloon angioplasty, which simply dilates the artery, the SELUTION SLR™ 018 DEB offers a unique approach by combining angioplasty with the delivery of sirolimus, a drug that helps prevent the artery from narrowing again. This drug-coated balloon provides a long-term, localized treatment effect lasting over 90 days, potentially reducing the risk of restenosis. Researchers are excited about this treatment because it could offer improved outcomes for patients with Peripheral Arterial Disease, enhancing arterial healing and maintaining blood flow more effectively than current options.

What evidence suggests that the SELUTION SLR™ 018 DEB is effective for peripheral arterial disease?

Research has shown that the SELUTION SLR™ 018 DEB, which participants in this trial may receive, effectively treats peripheral artery disease (PAD). Studies indicate that it can safely and effectively prevent blood vessels from narrowing again. In various studies, this treatment has consistently produced positive results for managing complex PAD cases. Specifically, patients treated with the SELUTION SLR DEB experienced better outcomes, with their arteries remaining open for a long time. These findings suggest that this drug-coated balloon could be a strong option for those with PAD who need artery treatment. Another treatment option in this trial is the Plain (Uncoated) Balloon Angioplasty (PTA), which opens the artery by dilatation with a temporarily inserted and inflated balloon. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Adults with peripheral arterial disease in the superficial femoral or proximal popliteal artery, able to walk unassisted and expected to live more than a year. Women of childbearing age must test negative for pregnancy and use contraception post-treatment. Participants cannot have had recent surgeries or be scheduled for upcoming ones, nor can they have conditions like severe kidney issues, blood disorders, allergies to Sirolimus, or be breastfeeding.

Inclusion Criteria

I am a woman able to have children, have a recent negative pregnancy test, and will use birth control for a year after treatment.

I can receive treatment for outflow disease but not with drug-eluting devices.

The blood vessel being treated is between 4mm and 7mm in diameter.

Exclusion Criteria

Breast-feeding woman

I am allergic to Sirolimus or certain required medications for the procedure.

You have a stent in the artery that will be treated in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either the SELUTION SLR™ 018 DEB or plain balloon angioplasty

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of primary and secondary endpoints

12 months

Multiple visits over 12 months

Long-term Follow-up

Extended monitoring for secondary endpoints such as amputation-free survival and target lesion revascularization

2-5 years

What Are the Treatments Tested in This Trial?

Interventions

• Plain (Uncoated) Balloon Angioplasty (PTA)
• SELUTION SLR™ 018 DEB

Trial Overview

The trial is testing SELUTION SLR™ 018 DEB's safety and effectiveness against plain balloon angioplasty for treating narrowed arteries due to PAD. It focuses on patients' legs where the blood flow has been reduced because of blockages in specific arteries.

How Is the Trial Designed?

Group I: SELUTION SLR™ 018 DEB Experimental Treatment 1 Intervention

Treatment with Selution SLR drug eluting balloon to apply long term (\>90 days) local treatment with sirolimus

Group II: Plain (Uncoated) Balloon Angioplasty (PTA) Active Control 1 Intervention

Opening artery only by dilatation with an temporary inserted and inflated balloon.

SELUTION SLR™ 018 DEB is already approved in European Union, Japan, United States for the following indications:

Approved in European Union as SELUTION SLR for:

• Peripheral artery disease
• Chronic limb-threatening ischemia
• Below-the-knee artery disease

Approved in Japan as SELUTION SLR for:

• Superficial femoral artery disease
• Popliteal artery disease

Approved in United States as SELUTION SLR for:

• Investigational Device Exemption (IDE) approval for below-the-knee indications in peripheral artery disease

Who Is Running the Clinical Trial?

M.A. Med Alliance S.A.

Lead Sponsor

Trials

9

Recruited

6,300+

MedAlliance, LLC

Lead Sponsor

Trials

2

Recruited

680+

Cordis Corporation

Industry Sponsor

Trials

96

Recruited

126,000+

Scott Drake

Cordis Corporation

Chief Executive Officer since 2023

Bachelor's degree in Business Administration from Miami University

Dr. Richard Afable

Cordis Corporation

Chief Medical Officer since 2021

MD from Loyola Stritch School of Medicine

Cordis US Corp.

Industry Sponsor

NAMSA

Collaborator

Trials

55

Recruited

21,500+

Published Research Related to This Trial

In a first-in-human trial involving 50 subjects with moderate to severe lower limb ischemia, the SELUTION sustained-limus-release drug-eluting balloon demonstrated significant efficacy by achieving a median angiographic late lumen loss of only 0.19 mm at 6 months, well below the objective performance criterion of 1.04 mm.

The SELUTION SLR DEB also showed a high rate of primary patency at 88.4% and a low incidence of major adverse events, indicating it is a safe and effective treatment option for patients with symptomatic femoropopliteal disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-Month Outcomes From the First-in-Human, Single-Arm SELUTION Sustained-Limus-Release Drug-Eluting Balloon Trial in Femoropopliteal Lesions. Zeller, T., Brechtel, K., Meyer, DR., et al.[2020]

The Selution SLR™ drug-coated balloon (DCB) demonstrated a 100% procedural success rate in a study of 78 patients with complex coronary artery lesions, indicating its safety and feasibility for use in percutaneous coronary intervention (PCI).

After a median follow-up of 11.2 months, the rate of major adverse cardiovascular events (MACE) was low at 6.8%, suggesting that the DCB strategy may effectively reduce complications in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metal free percutaneous coronary interventions in all-comers: First experience with a novel sirolimus-coated balloon. Madanchi, M., Cioffi, GM., Attinger-Toller, A., et al.[2023]

Recent advancements in endovascular techniques for treating peripheral arterial occlusive disease have led to high technical success rates and low complication rates, but in-stent restenosis remains a significant challenge for long-term outcomes.

Drug-eluting balloons (DEB), particularly those coated with paclitaxel, show promise in treating in-stent restenosis in peripheral arteries, but more extensive clinical trials are needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel-coated balloon angioplasty for lower extremity revascularization: a new way to fight in-stent restenosis. Manzi, M., Cester, G., Palena, LM.[2016]

Drug-coated balloons (DCB) offer several advantages over traditional angioplasty and stent technologies, including effective drug delivery directly to the vessel wall, immediate drug release without polymers, and the potential for reduced restenosis rates.

Clinical trials have shown DCB to be effective for treating coronary in-stent restenosis and peripheral artery disease, with promising applications for complex lesions and in patients who cannot use drug-eluting stents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opportunities and limitations of drug-coated balloons in interventional therapies. Scheller, B.[2021]

The SELUTION DeNovo trial is a large-scale study involving 3,326 patients across 50 sites in Europe and Asia, comparing the effectiveness of a novel sirolimus-eluting balloon (SEB) combined with provisional drug-eluting stents (DES) against a strategy using systematic DES for treating coronary artery lesions.

The primary goal is to determine if the SEB strategy is non-inferior to the systematic DES approach in preventing target vessel failure (TVF) over a follow-up period of up to five years, with additional assessments on safety, bleeding events, and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing a strategy of sirolimus-eluting balloon treatment to drug-eluting stent implantation in de novo coronary lesions in all-comers: Design and rationale of the SELUTION DeNovo Trial. Spaulding, C., Krackhardt, F., Bogaerts, K., et al.[2023]

In the IN.PACT SFA Trial involving 331 patients, the paclitaxel-coated drug-coated balloon (DCB) demonstrated significantly higher primary patency rates (82.2%) compared to percutaneous transluminal angioplasty (PTA) (52.4%) at 12 months, indicating better long-term effectiveness in treating superficial femoral and popliteal artery disease.

The DCB also had a much lower rate of clinically driven target lesion revascularization (2.4% vs. 20.6% for PTA), while both treatments showed low rates of vessel thrombosis and no major complications, highlighting the DCB's favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Tepe, G., Laird, J., Schneider, P., et al.[2022]

In a multicenter trial involving 171 patients, the novel paclitaxel-coated drug-coated balloon (DCB) significantly reduced late lumen loss by 0.92 mm compared to uncoated balloon angioplasty (POBA) at six months, indicating better efficacy in preventing restenosis.

Patients treated with the DCB showed improved walking ability and a much lower rate of target lesion revascularization (1.3% in the DCB group vs. 18.7% in the POBA group) after 12 months, demonstrating both safety and effectiveness of the DCB in treating peripheral artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a novel paclitaxel-nano-coated balloon for femoropopliteal angioplasty: one-year results of the EffPac trial. Teichgräber, U., Lehmann, T., Aschenbach, R., et al.[2020]

In a study of 442 patients, the drug-coated balloon (DCB) treatment showed non-inferior safety compared to percutaneous transluminal angioplasty (PTA), with freedom from major adverse limb events and perioperative death at 30 days being 99.3% for DCB and 99.4% for PTA.

At 6 months, DCB demonstrated statistically significant improved efficacy in treating infrapopliteal arterial lesions, particularly in the proximal-segment group, with a primary efficacy endpoint success rate of 76% for DCB compared to 62.9% for PTA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-Coated vs Uncoated Percutaneous Transluminal Angioplasty in Infrapopliteal Arteries: Six-Month Results of the Lutonix BTK Trial. Mustapha, JA., Brodmann, M., Geraghty, PJ., et al.[2020]

The SELUTION SLR™ drug-eluting balloon system uses a biodegradable polymer to create micro-reservoirs for sirolimus, allowing for controlled drug release and improved treatment of femoropopliteal artery lesions.

This system represents a significant advancement in endovascular therapy, as it combines the benefits of sirolimus with a novel coating formulation, potentially enhancing vessel patency compared to traditional drug-coated balloons that primarily used paclitaxel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SELUTION SLR™ drug-eluting balloon system for the treatment of symptomatic femoropopliteal lesions. Böhme, T., Noory, E., Beschorner, U., et al.[2021]

Citations

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Cordis Announces Positive Results from Two Major ...

The studies confirm the sustained efficacy and safety of SELUTION SLR DEB in treating complex peripheral artery disease (PAD) across diverse, real-world ...

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Cordis Selution SLR DEB Evaluated in Two Studies of ...

The studies confirm the sustained efficacy and safety of the Selution SLR in treating complex peripheral artery disease (PAD) across diverse, real-world ...

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pubmed.ncbi.nlm.nih.gov/32666871/

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Conclusion: Through 6 months, the SELUTION SLR DEB appears to inhibit restenosis effectively and safely, improving outcomes in subjects with ...

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drugdeliverybusiness.com/cordis-multiple-positive-studies-drug-eluting-balloon/

Cordis shares positive results from 2 drug-eluting balloon ...

According to Cordis, the studies confirmed the sustained efficacy and safety of Selution SLR in treating complex peripheral artery disease (PAD) ...

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Study Details | NCT05132361 | SELUTION4SFA Trial

This study aims to demonstrate the safety and efficacy of the SELUTION SLR™ 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of ...

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Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting ...

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SELUTION SLR PTA Drug Eluting Balloon - Cordis

SELUTION SLR™ PTCA Balloon is the latest in drug-eluting balloons designed to deliver consistent and predictable Limus drug release over 90 days.

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The 36-month follow-up data have already been presented, demonstrating the long-term safety and efficacy of SELUTION SLR™ DEB in the treatment ...