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SELUTION SLR™ for Coronary Restenosis (SELUTION4ISR Trial)

N/A
Recruiting
Led By Ron Waksman, MD
Research Sponsored by M.A. Med Alliance S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Target lesion is within a previously placed BMS or DES and does not extend further than 5 mm beyond either the proximal or distal edge of the stent
Target lesion has diameter stenosis of > 50% and ≤ 99% by visual estimate
Must not have
Target lesion is a total occlusion or has evidence of thrombus
Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months
Awards & highlights

Summary

This trial compares two treatments for patients who have had a previous stent placed in their artery and are experiencing a blockage in the stent. Patients will be randomly assigned to receive either a drug-co

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include bleeding due to antiplatelet therapy, potential artery re-narrowing, reactions at the catheter insertion site, and general complications related to heart interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My target lesion is inside a stent and doesn't extend more than 5mm beyond its edges.
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My target lesion is more than half but not completely blocked.
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My heart condition involves a main artery or its major branch.
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I have chronic heart issues and am scheduled for a heart procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My target lesion is completely blocked or has a clot.
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I am allergic to Sirolimus or similar medications.
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I am scheduled for treatment on multiple lesions in my blood vessels.
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I haven't had a stomach ulcer or GI bleeding in the last 6 months.
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My treatment targets a lesion at a vessel branching point.
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My target vessel has had or will have brachytherapy.
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I have severe kidney problems or have had a kidney transplant.
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My target lesion still has significant narrowing after initial treatment.
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I am not pregnant, breastfeeding, or at risk of becoming pregnant without contraception.
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My heart condition involves a blockage in the main artery.
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My kidney function has recently worsened.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Target Lesion Failure
Secondary study objectives
Device success
In-segment minimal luminal diameter (MLD)
Lesion Success
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SELUTION SLR™ DEBExperimental Treatment1 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 TreatmentActive Control1 Intervention
POBA or FDA-approved -limus DES

Find a Location

Who is running the clinical trial?

GenaeIndustry Sponsor
8 Previous Clinical Trials
1,861 Total Patients Enrolled
Baim Institute for Clinical ResearchOTHER
28 Previous Clinical Trials
55,232 Total Patients Enrolled
2 Trials studying Coronary Restenosis
920 Patients Enrolled for Coronary Restenosis
M.A. Med Alliance S.A.Lead Sponsor
8 Previous Clinical Trials
5,823 Total Patients Enrolled
~81 spots leftby Sep 2025
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