Drug-Coated Balloon Angioplasty for Peripheral Arterial Disease

Recruiting at 47 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

300 Participants Needed

Trial Summary

What is the purpose of this 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 peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).

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 data supports the effectiveness of the drug-coated balloon treatment for peripheral arterial disease?

Research shows that the SELUTION SLR drug-coated balloon treatment significantly reduces the narrowing of blood vessels (restenosis) in patients with femoropopliteal artery disease, with a high rate of keeping the vessels open (88.4% primary patency) and minimal adverse events over six months. ^{1 2 3 4 5}

How is the SELUTION SLR drug different from other treatments for peripheral arterial disease?

The SELUTION SLR drug-coated balloon is unique because it uses a biodegradable polymer to create micro-reservoirs that control the release of sirolimus, a drug that was previously limited in use due to short residency time in the vessel wall. This approach differs from traditional drug-coated balloons that typically use paclitaxel and do not have this controlled release mechanism. ^{2 6 7 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

NAMSA

Collaborator

Trials

55

Recruited

21,500+

Findings from Research

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-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]

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]

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]

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]

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]

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]

References

1. United States 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. [2020]

2. England pubmed.ncbi.nlm.nih.gov

The SELUTION SLR™ drug-eluting balloon system for the treatment of symptomatic femoropopliteal lesions. [2021]

3. Poland pubmed.ncbi.nlm.nih.gov

Metal free percutaneous coronary interventions in all-comers: First experience with a novel sirolimus-coated balloon. [2023]

4. United States 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. [2023]

5. Italy pubmed.ncbi.nlm.nih.gov

Paclitaxel-coated balloon angioplasty for lower extremity revascularization: a new way to fight in-stent restenosis. [2016]

6. United States 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. [2022]

7. France 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. [2020]

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

Drug-Coated vs Uncoated Percutaneous Transluminal Angioplasty in Infrapopliteal Arteries: Six-Month Results of the Lutonix BTK Trial. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

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