SELUTION SLR™ for Coronary Restenosis

(SELUTION4ISR Trial)

Recruiting at 62 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

418 Participants Needed

Trial Summary

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).

What data supports the effectiveness of the treatment SELUTION SLR™ DEB for coronary restenosis?

Research shows that drug-eluting stents, which release drugs like sirolimus, can significantly reduce the recurrence of artery narrowing (restenosis) after procedures to open blocked arteries. This suggests that similar treatments, like SELUTION SLR™ DEB, may also be effective in preventing restenosis. ^{1 2 3 4 5}

Is the SELUTION SLR™ treatment generally safe for humans?

The SELUTION SLR™ drug-eluting balloon has been tested in humans for treating femoropopliteal lesions (blockages in leg arteries), and the study found it to be safe with no major adverse events reported over six months. ^{5 6 7 8 9}

What makes the drug SELUTION SLR™ DEB unique for treating coronary restenosis?

SELUTION SLR™ DEB is unique because it uses a drug-eluting balloon (DEB) to deliver medication directly to the site of coronary restenosis, potentially reducing the risk of re-narrowing of the artery. This method differs from traditional stents as it does not leave a permanent implant in the artery, which may reduce long-term complications. ^{10 11 12 13 14}

What is the purpose of this trial?

Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial. Subjects with previous bare-metal stent (BMS) or DES and qualifying evidence for ISR will be screened per the protocol inclusion and exclusion criteria. Eligible subjects will be randomized 1:1 to treatment with either the SELUTION SLR™ 014 DEB or SOC to include contemporary DES (zotarolimus-eluting stents \[ZES\] and everolimus-eluting stents \[EES\] only) or BA. A maximum of 20% of patients randomized to SOC will be treated with BA. The primary endpoint will be Target Lesion Failure (TLF) at 12-months in the SOC group vs. the SELUTION SLR™ 014 DEB in all patients.

Research Team

Donald E Cutlip, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

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

Findings from Research

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[State of treatment of coronary artery disease by drug releasing stents]. [2019]

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

Drug-eluting stents for cardiovascular disorders. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Oral administration of glycine in the prevention of restenosis after coronary angioplasty. A double blind placebo controlled randomized feasibility trial evaluating safety and efficacy of glycine in the prevention of restenosis after angioplasty. [2016]

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

A blinded, randomized, placebo-controlled trial of percutaneous laser myocardial revascularization to improve angina symptoms in patients with severe coronary disease. [2022]

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

Drug-coated stents: preventing restenosis in coronary artery disease. [2019]

6. 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]

7. Germany pubmed.ncbi.nlm.nih.gov

Treatment of in-stent restenosis with sirolimus-eluting-stents: results from the prospective German Cypher stent registry. [2021]

8. Poland pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Drug-eluting stents: a critique. [2010]

10. Japan pubmed.ncbi.nlm.nih.gov

Effects of Leukotriene B(4) Receptor Antagonist on Experimental Autoimmune Uveoretinitis in Rats. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Characterisation of the peptido-leukotriene receptor PL2 on the ferret spleen strip. [2019]

12. Denmark pubmed.ncbi.nlm.nih.gov

Reproducibility of leukotriene D4 inhalation challenge in asthmatics. Effect of a novel leukotriene D4/E4-antagonist (SR 2640) on leukotriene D4-induced bronchoconstriction. [2019]

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

Leukotriene D4 reduces coronary blood flow in the anesthetized dog. [2019]

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

Antagonism of the cardiac effects of leukotriene C4 by compound SKF 88046: dissociation of effects on contractility and coronary flow. [2018]