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

Recruiting at 26 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

Trial Summary

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 data supports the effectiveness of the SELUTION SLR treatment for coronary artery disease?

The Selution SLR drug-coated balloon (DCB) is a new treatment that releases a drug called sirolimus, which helps prevent the artery from narrowing again after a procedure. It has shown promise in treating complex coronary artery lesions, suggesting it could be effective for coronary artery disease. ^{1 2 3 4 5}

Is the SELUTION SLR DCB and -limus DES safe for humans?

Research shows that various -limus drug-eluting stents, including sirolimus and zotarolimus types, have been studied for safety, with some concerns about issues like in-stent restenosis (narrowing of the stent) and very late stent thrombosis (blood clot formation). The SELUTION SLR drug-coated balloon has been evaluated for safety in treating certain artery diseases, indicating it is generally safe for human use. ^{1 2 3 6 7}

What makes the SELUTION SLR DCB drug unique for treating coronary artery disease?

The SELUTION SLR drug-coated balloon (DCB) is unique because it uses a biodegradable polymer to create micro-reservoirs that release sirolimus, an antiproliferative drug, in a controlled manner. This approach aims to reduce issues like in-stent restenosis and very late stent thrombosis, which are concerns with traditional drug-eluting stents. ^{2 3 6 8 9}

What is the purpose of this trial?

Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA. The Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.

Research Team

Ron Waksman, M.D.

Principal Investigator

Medstar Health Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2016]

2. United States 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. [2022]

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

Coronary Stents in Diabetic Patients: State of the Knowledge. [2018]

5. United States 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. [2021]

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

Sirolimus-Coated Balloon in Femoropopliteal Steno-Occlusive Disease: Efficacy, Safety, and 1-Year Outcomes. An All-Comers Registry. [2023]

7. Netherlands 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. [2015]

8. England pubmed.ncbi.nlm.nih.gov

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

9. 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]