SELUTION SLR™ for Coronary Restenosis

(SELUTION4ISR Trial)

Not currently recruiting at 66 trial locations

Overseen By Michelle Alamo

Age: 18+

Sex: Any

Trial Phase: Academic

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

Must be taking: Dual antiplatelet therapy

Must not be taking: Sirolimus

Disqualifiers: STEMI, Renal insufficiency, LVEF < 25%, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment method for coronary restenosis, which occurs when an artery narrows again after stent treatment. Participants will receive either the SELUTION SLR™ drug-eluting balloon (a special balloon that releases medicine to help keep the artery open) or a standard treatment with drug-eluting stents or balloon angioplasty. The goal is to determine if the new treatment matches or surpasses the standard options. Individuals who have previously received a stent and experience issues like chest pain or artery narrowing might be suitable for this trial. As an unphased trial, this study explores innovative treatment options that could improve health outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be eligible for dual antiplatelet therapy (taking aspirin plus another medication like Clopidogrel, Prasugrel, or Ticagrelor).

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the SELUTION SLR™ drug-eluting balloon (DEB) is generally safe for people. Studies have found that patients tolerate the treatment well, with good safety results. In one study, patients reported no major safety issues or unexpected side effects from using the SELUTION SLR™ DEB. Another study demonstrated that the SELUTION SLR™ DEB is a safe option for patients with certain heart conditions. This suggests that the treatment is likely safe for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for coronary restenosis, which typically involve plain old balloon angioplasty (POBA) or drug-eluting stents (DES), the SELUTION SLR™ drug-eluting balloon (DEB) introduces a novel approach by using a balloon coated with Sirolimus. This unique delivery method allows the drug to be directly applied to the artery wall during angioplasty, potentially reducing restenosis by providing a sustained release of Sirolimus. Researchers are excited about this treatment because it combines the mechanical benefits of angioplasty with the therapeutic effects of a drug, all in one procedure, which could enhance effectiveness and reduce the risk of artery re-narrowing compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for coronary restenosis?

Research has shown that the SELUTION SLR™ Drug-Eluting Balloon (DEB), which participants in this trial may receive, could be a promising treatment for heart problems. Studies have found that it performs as well as traditional drug-eluting stents and reduces the need for additional stents. In trials, about 80% of patients treated with the DEB did not require more stents, which benefits those wanting to avoid extra procedures. The balloon is coated with sirolimus, a substance that helps prevent blood vessels from narrowing again after treatment. Overall, these findings suggest that the SELUTION SLR™ DEB could effectively manage the narrowing of blood vessels in the heart. ^{1 2 6 7 8}

Who Is on the Research Team?

Donald E Cutlip, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with coronary restenosis within a previously placed metal stent. Participants must be able to take dual antiplatelet therapy, have more than a year's life expectancy, and agree to study procedures. Pregnant women or those planning pregnancy are excluded.

Inclusion Criteria

Target lesion is ≤ 26 mm in length

Reference vessel diameter (RVD) is ≥ 2.00 mm and ≤ 4.50 mm

My target lesion is inside a stent and doesn't extend more than 5mm beyond its edges.

Exclusion Criteria

My target lesion is completely blocked or has a clot.

I am allergic to Sirolimus or similar medications.

I had a major heart attack within the last 30 days.

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™ 014 DEB or SOC treatment, including contemporary DES or BA

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a primary endpoint of Target Lesion Failure at 12 months

12 months

Angiographic and OCT sub-study

A subset of participants undergo planned angiographic and OCT follow-up within 30 days after completion of the 12-month primary endpoint clinical follow-up

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Control
• SELUTION SLR™ DEB

Trial Overview The trial compares the SELUTION SLR™ 014 drug-eluting balloon (DEB) against standard of care (DES or BA). It's randomized and single-blind, meaning patients don't know which treatment they get but researchers do. The main goal is to see if the DEB reduces lesion failure after one year.

How Is the Trial Designed?

Group I: SELUTION SLR™ DEB Experimental Treatment 1 Intervention

The SELUTION Sustained Limus Release (SLR)™ drug-eluting balloon (DEB) catheter is a combination product consisting of a standard percutaneous transluminal coronary angioplasty (PTCA) balloon catheter coated with a drug (Sirolimus).

Group II: Control Treatment Active Control 1 Intervention

POBA or FDA-approved -limus DES

Who Is Running the Clinical Trial?

M.A. Med Alliance S.A.

Lead Sponsor

Trials

9

Recruited

6,300+

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

Genae

Industry Sponsor

Trials

9

Recruited

2,300+

Baim Institute for Clinical Research

Collaborator

Trials

29

Recruited

55,700+

Iqvia Pty Ltd

Industry Sponsor

Trials

120

Recruited

177,000+

Ari Bousbib

Iqvia Pty Ltd

Chief Executive Officer since 2016

MBA from Columbia University, Master of Science in Mathematics and Mechanical Engineering from Ecole Superieure des Travaux Publics, Paris

Jeffrey Spaeder

Iqvia Pty Ltd

Chief Medical Officer

MD

Published Research Related to This Trial

The study identified a specific type of peptido-leukotriene receptor in the ferret spleen that responds to leukotrienes LTC4 and LTD4, producing significant contractions, while LTB4 was inactive, indicating a unique receptor profile.

Existing PL1 receptor antagonists were ineffective against the contractions induced by LTC4 and LTD4, suggesting that the ferret spleen's PL receptor is distinct and may help in developing new drugs targeting the PL2 receptor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterisation of the peptido-leukotriene receptor PL2 on the ferret spleen strip. Gardiner, PJ., Norman, P., Cuthbert, NJ., et al.[2019]

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]

Citations

1. cordis.com cordis.com/na/news/cordis-to-unveil-12-month-selution-slr-deb-trial-results

Cordis to Unveil 12-Month SELUTION SLR DEB Trial Results Cordis to unveil 12-month results from two SELUTION SLR™ DEB randomized clinical trials at TCT 2025 Late-Breaking Clinical Trials Session.

2. acc.org acc.org/Latest-in-Cardiology/Articles/2025/10/24/16/56/sun-222pm-combo-selution-tct-2025

New Science Compares Use of Sirolimus-Eluting Balloons ... Additionally, of those patients treated with DEB, 80% did not require a stent. "The SELUTION DeNovo trial provides the first comparison of a PCI ...

3. tctmd.com tctmd.com/news/sirolimus-coated-balloon-meets-mark-de-novo-lesions-and-isr-selution

Sirolimus-Coated Balloon Meets Mark in De Novo Lesions ... One-year results of the SELUTION DeNovo trial comparing a strategy of PCI with a sirolimus-eluting balloon and provisional stenting versus ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12305835/

Clinical Efficacy and Safety of Selution SLRTM Drug Coated ... The currently available data on Selution SLRTM appear promising. Preliminary data from the Prospective Registry Study to Evaluate the Outcomes of Coronary ...

5. prnewswire.com prnewswire.com/news-releases/cordis-unveiled-breakthrough-results-from-selution-denovo-and-selution4isr-randomized-trials-at-tct-2025-transforming-coronary-artery-disease-cad-treatment-beyond-stenting-302594716.html

Cordis Unveiled Breakthrough Results from SELUTION ... "SELUTION SLR™ DEB achieved results comparable to drug-eluting stents while reducing the need for stents. With this minimal stenting approach, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05946629

SELUTION 4 De Novo Small Vessel IDE Trial Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for ...

7. 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. ...

8. 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.