SELUTION SLR™ for Peripheral Arterial Disease

Recruiting at 44 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, SELUTION SLR™ (a drug-eluting balloon), for individuals with peripheral arterial disease (PAD) in their legs. Researchers aim to determine if this treatment is more effective and equally safe compared to the current method, which uses an uncoated balloon to open blocked arteries. The trial seeks participants who have experienced chronic limb-threatening ischemia (a condition with severely reduced blood flow) for more than two weeks. Participants should not have severe tissue damage or chronic kidney problems requiring dialysis. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance treatment options for PAD.

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 prior data suggests that the SELUTION SLR™ DEB 014 is safe for treating peripheral arterial disease?

Research has shown that the SELUTION SLR™ DEB 014, a special balloon that releases medication to treat peripheral arterial disease (PAD), is generally well-tolerated by patients. Studies have demonstrated that this treatment consistently releases its medication over 90 days, helping to reduce complications related to PAD.

For example, earlier research found that the SELUTION SLR™ device was safe and effective for treating blocked arteries in the legs. Some studies even reported positive safety results lasting over three years, indicating long-term safety for patients using this treatment.

In summary, the SELUTION SLR™ DEB 014 has shown promising safety data in previous studies. It appears well-tolerated with a low rate of side effects for those who have used it for similar conditions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SELUTION SLR™ DEB 014 is unique because it uses a drug-eluting balloon to treat Peripheral Arterial Disease (PAD). Unlike standard treatments like plain balloon angioplasty, which simply widen the arteries, SELUTION SLR™ releases a medication called sirolimus directly into the artery walls. This targeted delivery helps prevent the arteries from narrowing again, a common issue with traditional methods. Researchers are excited as this approach could lead to longer-lasting results and fewer repeat procedures.

What evidence suggests that the SELUTION SLR™ DEB 014 is effective for peripheral arterial disease?

Research has shown that the SELUTION SLR™ DEB 014, one of the treatments in this trial, effectively treats peripheral arterial disease (PAD), particularly in challenging cases. Studies have found that it steadily releases a drug called Limus over 90 days, helping to keep arteries open. Participants in this trial may receive the SELUTION SLR™ DEB 014, which has demonstrated better results compared to those treated with Plain (Uncoated) Balloon Angioplasty (PTA), the other treatment arm in this trial. Positive results from clinical studies highlight its safety and long-lasting effectiveness, indicating it works well without causing major side effects. Overall, the SELUTION SLR™ DEB 014 shows promise for treating PAD in various real-world situations. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Cordis US Corp.

Industry Sponsor

Published Research Related to This Trial

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-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]

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]

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]

Citations

1. cordis.com cordis.com/emea/products/peripheral-interventions/lower-extremities/selution-slr-drug-eluting-pta-balloon/selution-slr-pta-drug-eluting-balloon

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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10021111/

Intervention with selution SLR™ Agent Balloon for ... The aim of this pilot clinical study is to evaluate the safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-coated balloon (M.A. ...

3. cordis.com cordis.com/emea/news/cordis-announces-positive-results-from-two-major-clinical-studies.

Cordis Announces Positive Results from Two Major Clinical… The studies confirm the sustained efficacy and safety of SELUTION SLR DEB in treating complex peripheral artery disease (PAD) across diverse, real-world ...

4. jacc.org jacc.org/doi/10.1016/j.jcin.2024.03.029

The SELUTION SFA Japan Trial | ... The SELUTION SFA JAPAN trial demonstrated that a novel SELUTION SCB is a safe and effective treatment option for FP disease in symptomatic patients.

5. evtoday.com evtoday.com/news/cordis-selution-slr-deb-evaluated-in-two-studies-of-complex-pad-patients

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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05132361

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 ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ccd.31696?af=R

Long‐Term Efficacy and Safety of Sirolimus‐Coated ... These 3-year findings suggest long-term efficacy and safety of SELUTION SCB in the setting of femoropopliteal steno-occlusive endovascular treatment.