SELUTION SLR DCB vs. "-limus" DES for Coronary Artery Disease

Recruiting at 41 trial locations

Overseen By Rebecca Apruzzese

Age: 18+

Sex: Any

Trial Phase: Academic

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

Must be taking: Dual antiplatelet therapy

Must not be taking: Strong CYP3A4 inhibitors, inducers

Disqualifiers: Heart failure, STEMI, others

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

Compensation: Varies

Number of Visits: 1

Duration: Up to 7 days

960 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to compare the safety and effectiveness of two treatments for individuals with small coronary artery disease (narrowing of heart arteries). The new treatment uses a special balloon called the SELUTION SLR DEB, while the other employs a standard stent (a -limus drug-eluting stent). Both methods help open blocked arteries. Candidates with stable or unstable angina (chest pain) or a recent small heart attack may qualify if they can tolerate certain heart medications and require a procedure for a specific artery blockage. As an unphased trial, this study provides patients the chance to contribute to significant research that could enhance treatment options for coronary artery disease.

Will I have to stop taking my current medications?

The trial requires that participants can tolerate dual antiplatelet therapy with aspirin and another medication like Clopidogrel, Prasugrel, or Ticagrelor. If you are taking strong CYP3A4 inhibitors or inducers, you may need to stop them 14 days before the procedure and during the study period. The protocol does not specify other medication restrictions, so it's best to discuss your current medications with the study team.

What prior data suggests that the SELUTION SLR 014 PTCA DEB is safe for treating coronary artery disease?

Research has shown that the SELUTION SLR 014 PTCA DEB, a special balloon coated with the drug sirolimus, has undergone testing in several studies. Patients generally tolerated the treatment well, with few major problems. Over a 12-month follow-up, no major safety issues emerged, which is encouraging for those considering participation in trials with this treatment.

The FDA has approved "-limus" drug-eluting stents for other uses, and their safety is well-known. These stents release medicine that helps keep arteries open and are usually safe, with manageable side effects.

Both treatments aim to improve blood flow in small heart vessels and are designed to reduce complications. This information suggests that both treatment options have been well-tolerated by patients in the past. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about SELUTION SLR 014 because it offers a fresh approach to treating coronary artery disease. Unlike standard treatments that use drug-eluting stents (DES) coated with "-limus" drugs like Sirolimus or Everolimus, SELUTION SLR is a drug-eluting balloon (DEB) that delivers Sirolimus directly to the artery wall during angioplasty. This method potentially reduces the risk of complications associated with permanent stents, like blood clots or scar tissue formation. By releasing Sirolimus in a targeted, sustained way, SELUTION SLR aims to enhance artery healing and improve patient outcomes.

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

This trial will compare the SELUTION SLR 014 PTCA DEB with "-limus" drug-eluting stents (DES) for treating coronary artery disease. Research shows that the SELUTION SLR 014 PTCA DEB may effectively treat small blockages in heart arteries. Previous studies on this drug-coated balloon showed good results for patients with new artery blockages. The device releases sirolimus, which helps keep the artery open. This method has proven safe and effective in improving blood flow. Trial data suggest it could be useful in managing heart artery disease. ^{2 3 4 6 7}

Who Is on the Research Team?

Ron Waksman, M.D.

Principal Investigator

Medstar Health Research Institute

Are You a Good Fit for This Trial?

This trial is for adults with small vessel coronary artery disease who need PCI and can tolerate dual antiplatelet therapy. They should not be pregnant, planning surgery within 30 days, or have severe heart failure. Participants must be willing to follow study procedures and use contraception if applicable.

Inclusion Criteria

Subject has life expectancy > 1 year in the opinion of the investigator

My target lesion is highly likely (>70%) to respond well to specific pre-treatment and DEB.

Target vessel has RVD of ≥ 2.00 mm and ≤ 2.75 mm [by visual assessment]

Exclusion Criteria

Subjects who meet any of the following clinical criteria will be excluded from the trial:

I am scheduled for treatment on a lesion near the beginning of my aorta.

I am allergic to Sirolimus or similar medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with either the SELUTION SLR 014 PTCA DEB or a contemporary DES for de novo coronary lesions in small vessels

Up to 7 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including angiography at 12 months for the angiographic substudy

12 months

Multiple visits (in-person and virtual)

Long-term Follow-up

Participants are monitored for long-term safety and effectiveness outcomes

5 years

What Are the Treatments Tested in This Trial?

Interventions

• -limus DES
• SELUTION SLR 014 PTCA DEB

Trial Overview The SELUTION SLR DCB device is being tested against FDA-approved '-limus' DES in treating de novo lesions in small coronary vessels. This randomized controlled trial aims to enroll up to 910 subjects across multiple countries.

How Is the Trial Designed?

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

SELUTION Sustained Limus Release (SLR) 014 Percutaneous Transluminal Coronary Angioplasty (PTCA) Drug Eluting Balloon (DEB) The SELUTION SLR 014 PTCA DEB is a minimally invasive, single use and sterile Sirolimus coated PTCA balloon catheter. The SELUTION SLR 014 PTCA DEB is available with balloon diameters from 2.0 to 3.0 mm and lengths of 15 to 40 mm for the purpose of the De Novo IDE trial

Group II: Control Treatment Active Control 1 Intervention

any FDA approved "limus-based" Drug Eluting Stent, as per standard institutional practice

-limus DES is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Limus drug-eluting stent for:

• Coronary artery disease
• Peripheral artery disease

Approved in United States as Limus drug-eluting stent for:

• Coronary artery disease
• Peripheral artery disease

Approved in Canada as Limus drug-eluting stent for:

• Coronary artery disease
• Peripheral artery disease

Approved in Japan as Limus drug-eluting stent for:

• Coronary artery disease
• Peripheral artery disease

Who Is Running the Clinical Trial?

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 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]

In randomized controlled trials (RCTs) involving 11,778 patients, everolimus-eluting stents (EES) and zotarolimus-eluting stents (ZES) showed comparable safety and efficacy, indicating no significant advantage for either stent type.

However, in observational studies with 34,850 patients, EES demonstrated a significantly lower risk of major adverse cardiac events (MACE), stent thrombosis (ST), and the need for target vessel revascularization (TVR) compared to ZES, suggesting that EES may be a safer and more effective option in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of everolimus-eluting stent versus zotarolimus-eluting stent: A meta-analysis of randomized controlled clinical trials and observational studies. Gu, H., Hua, K., Li, W., et al.[2015]

Recent studies indicate that everolimus-eluting stents are safer and more effective than paclitaxel-eluting stents for diabetic patients with coronary artery disease, suggesting a preference for everolimus in treatment.

There is strong evidence supporting the use of drug-eluting stents (DES) over bare metal stents in diabetic patients, with ongoing research into new stent technologies showing promising results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary Stents in Diabetic Patients: State of the Knowledge. Codner, P., Gurm, HS., Motivala, A.[2018]

The Selution Sustained Limus Release (SLR) sirolimus-eluting balloon demonstrated a 100% technical success rate and an 81.5% primary tibial patency at 6 months in a pilot study of 25 patients with chronic limb-threatening ischemia (CLTI).

The treatment resulted in significant clinical improvements, with the mean Rutherford score decreasing from 5.00 to 1.14, and an amputation-free survival rate of 84.0%, indicating both safety and efficacy in a high-risk patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

World's First Experience Treating TASC II C and D Tibial Occlusive Disease Using the Selution SLR Sirolimus-Eluting Balloon: Six-Month Results From the PRESTIGE Study. Tang, TY., Yap, C., Soon, SXY., et al.[2021]

In a study involving 1,007 patients, the new-generation sirolimus- and probucol-eluting stent (Dual-DES) showed a significant advantage in reducing target lesion revascularization (TLR) rates at 2 years compared to sirolimus-eluting stents (SES), with TLR rates of 7.7% for Dual-DES versus 10.7% for SES.

There were no significant differences in safety outcomes, such as death, myocardial infarction, or stent thrombosis, among the three stent types, indicating that Dual-DES is as safe as SES and zotarolimus-eluting stents (ZES) while providing better long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2-year clinical and angiographic outcomes from a randomized trial of polymer-free dual drug-eluting stents versus polymer-based Cypher and Endeavor [corrected] drug-eluting stents. Byrne, RA., Kastrati, A., Tiroch, K., et al.[2022]

Resolute zotarolimus-eluting stents (R-ZES) are more effective than Endeavor zotarolimus-eluting stents (E-ZES) in preventing the need for further procedures (ID-TVR), while showing similar safety profiles regarding myocardial infarction, cardiac death, and stent thrombosis.

Endeavor zotarolimus-eluting stents (E-ZES) are associated with a higher risk of reintervention compared to other limus-eluting stents, indicating that R-ZES may be a better option for patients undergoing percutaneous coronary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two zotarolimus-eluting stent generations: a meta-analysis of 12 randomised trials versus other limus-eluting stents and an adjusted indirect comparison. Cassese, S., Ndrepepa, G., King, LA., et al.[2016]

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 SLR (SELUTION sustained-limus-release) drug-coated balloon demonstrated a high primary patency rate of 86.3% and a freedom from clinically-driven target lesion revascularization (CD-TLR) rate of 96.2% at 12 months, indicating its efficacy in treating femoropopliteal steno-occlusive disease in 80 patients.

The safety profile was strong, with a primary safety outcome of 98.7% at 30 days and 97.5% at 12 months, suggesting that the sirolimus-coated balloon is a safe treatment option with a lower risk of complications compared to other drug-coated devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sirolimus-Coated Balloon in Femoropopliteal Steno-Occlusive Disease: Efficacy, Safety, and 1-Year Outcomes. An All-Comers Registry. Franzese, M., Pucciarelli, A., Spione, F., et al.[2023]

Citations

1. 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 ...

2. cordis.com cordis.com/na/news/cordis-unveils-positive-results-for-two-seluton-slr-deb-trials

Cordis Unveils Positive Results for Two SELUTON SLR DEB… These trials demonstrate safe and efficacious results for SELUTION SLR™ DEB in treating complex de novo and ISR lesions, providing a real ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0002870323000108

Comparing a strategy of sirolimus-eluting balloon treatment ... SELUTION DeNovo trial is an open-label, multi-center international randomized trial comparing a strategy of PCI with SEB and provisional DES to a strategy of ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39952378/

Prospective randomized single-blind multicenter study to ... The SELUTION4ISR study will evaluate the safety and effectiveness of SLR DEB in a prospective, randomized, international, multicenter trial for treatment of ...

5. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/SEL-003-2021

SELUTION SLR Drug Eluting Balloon in De Novo Coronary ... The purpose of this study is to determine whether an experimental device called the SELUTION SLR drug eluting balloon is safe and whether it works.

6. 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.

7. dicardiology.com dicardiology.com/content/medalliance-selution-slr-first-deb-receive-coronary-de-novo-ide-approval-its-fourth-fda-ide

MedAlliance Selution SLR is the First DEB to Receive ... The Selution SLR coronary de novo study is the first of its kind in the USA and will provide important data on the efficacy and safety of ...