SELUTION SLR™ for Peripheral Arterial Disease

Recruiting at 42 trial locations

Overseen By Robert Beasley, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MedAlliance, LLC

Must not be taking: Antiplatelets, Sirolimus, Chemotherapy, others

Disqualifiers: Renal insufficiency, Acute limb ischemia, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-procedure

376 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a special balloon called SELUTION SLR™ DEB 014 for patients with severe leg artery blockages. The balloon helps open the artery and releases medicine to prevent it from getting blocked again.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

What data supports the effectiveness of the SELUTION SLR™ treatment for Peripheral Arterial Disease?

Research shows that the SELUTION SLR™ drug-eluting balloon significantly reduces the narrowing of blood vessels (restenosis) and improves blood flow in patients with femoropopliteal artery disease, with a high rate of vessel patency (openness) and minimal adverse events over six months. ^{1 2 3 4 5}

Is the SELUTION SLR™ treatment generally safe for humans?

The SELUTION SLR™ drug-eluting balloon has been shown to be generally safe in humans, with a study reporting no major adverse events over six months in patients with femoropopliteal disease. This suggests it is safe for use in treating certain vascular conditions. ^{1 3 4 5 6}

What makes the SELUTION SLR™ treatment unique for Peripheral Arterial Disease?

The SELUTION SLR™ treatment is unique because it uses a drug-eluting balloon that releases sirolimus, an antiproliferative drug, through biodegradable micro-reservoirs, which helps maintain vessel patency without leaving a permanent implant like a stent. This approach reduces the risk of complications such as restenosis (re-narrowing of the vessel) and very late stent thrombosis. ^{1 3 4 5 6}

Eligibility Criteria

This trial is for adults with chronic limb-threatening ischemia in the lower limbs, who have a life expectancy of at least one year and can follow study procedures. They must not be pregnant or breastfeeding and agree to use contraception if applicable. The disease should be classified as Rutherford category 4-6, affecting arteries below the knee but above the ankle without severe blockages elsewhere.

Inclusion Criteria

My target lesion is in the artery below my knee and above my ankle, and it's either new or has not been treated with a stent before.

Target vessel reference diameter(s) are ≥ 2mm and ≤ 4mm

Subject life expectancy is ≥ 1 year

Exclusion Criteria

I have a systemic infection.

I have severe kidney problems or have had a kidney transplant.

I have had, or will have, a major leg amputation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the SELUTION SLR™ DEB 014 or plain balloon angioplasty for the treatment of BTK atherosclerotic disease

Immediate post-procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 6, 12, 24, and 36 months

36 months

Multiple visits (in-person and virtual)

Long-term follow-up

Participants continue to be monitored for long-term outcomes such as amputation-free survival and major cardiovascular events

Up to 5 years

Treatment Details

Interventions

• Plain (Uncoated) Balloon Angioplasty (PTA)
• SELUTION SLR™ DEB 014

Trial Overview The SELUTION SLR™ DEB 014 drug-coated balloon is being tested against plain balloon angioplasty for treating peripheral arterial disease in arteries below the knee. The goal is to see if it's more effective and just as safe.

Participant Groups

Group I: SELUTION SLR™ DEB 014 Experimental Treatment 1 Intervention

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

SELUTION SLR™ DEB 014 is already approved in European Union, United States, Japan for the following indications:

Approved in European Union as SELUTION SLR for:

• Peripheral artery disease
• Coronary artery disease
• Below-the-knee (BTK) indications
• Superficial femoral artery (SFA) occlusive disease
• Coronary in-stent restenosis (ISR)

Approved in United States as SELUTION SLR for:

• Investigational for coronary de novo lesions, below-the-knee (BTK) indications, superficial femoral artery (SFA) occlusive disease, and coronary in-stent restenosis (ISR)

Approved in Japan as SELUTION SLR for:

• Superficial femoral artery (SFA) and popliteal artery (PA) lesions

Who Is Running the Clinical Trial?

MedAlliance, LLC

Lead Sponsor

Trials

2

Recruited

680+

M.A. Med Alliance S.A.

Lead Sponsor

Trials

9

Recruited

6,300+

NAMSA

Collaborator

Trials

55

Recruited

21,500+

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

Findings from Research

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]

A meta-analysis of 4 randomized trials found that drug-eluting balloons (DEB) and standard percutaneous transluminal angioplasty (PTA) show similar one-year outcomes for treating infrapopliteal arterial occlusive disease, with no significant differences in target lesion revascularization, binary restenosis, or late lumen loss.

Both DEB and PTA resulted in comparable rates of major adverse events, indicating that neither method is superior in terms of safety or efficacy based on the current evidence, highlighting the need for further large-scale studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-eluting balloon versus standard percutaneous transluminal angioplasty in infrapopliteal arterial disease: A meta-analysis of randomized trials. Wu, R., Tang, S., Wang, M., et al.[2022]

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 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 Sustained Limus Release (SLR) sirolimus-coated balloon shows promise for improving the patency of failing arterio-venous fistulas in hemodialysis patients, with a focus on safety and efficacy in a pilot study involving 40 patients.

Pre-clinical studies indicate that the sirolimus coating has prolonged retention in arterial tissue and demonstrates safety with no significant adverse effects, suggesting it may be a viable alternative to existing treatments for conduit stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention with selution SLR™ Agent Balloon for Endovascular Latent Limus therapy for failing AV Fistulas (ISABELLA) Trial: Protocol for a pilot clinical study and pre-clinical results. Tang, TY., Chong, TT., Yap, CJQ., et al.[2023]

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]

References

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

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

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

Drug-eluting balloon versus standard percutaneous transluminal angioplasty in infrapopliteal arterial disease: A meta-analysis of randomized trials. [2022]

3. 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]

4. 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]

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

Intervention with selution SLR™ Agent Balloon for Endovascular Latent Limus therapy for failing AV Fistulas (ISABELLA) Trial: Protocol for a pilot clinical study and pre-clinical results. [2023]

6. Poland pubmed.ncbi.nlm.nih.gov

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