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SELUTION 4 Trial for Coronary Artery Disease

This study is testing a new device called the SELUTION SLR DCB (Drug-Coated Balloon) for treating coronary artery disease in small blood vessels of the heart. This condition involves blockages in the arteries that supply blood to your heart. The SELUTION SLR DCB is being compared to standard FDA-approved stents (small mesh tubes placed in arteries to keep them open) that release medicine, called "-limus" DES. The goal is to see if the SELUTION SLR DCB is safe and effective. You may be able to join if you are 18 or older and have blockages in small coronary arteries that need treatment. The study aims to enroll about 960 participants. We will measure how well the treatment works after 12 months by looking at "target lesion failure" (problems with the treated area). The current recruitment status is unclear.

Study design
This is a randomized, controlled study, meaning participants are randomly assigned to receive either the SELUTION SLR DCB or a standard DES. It is single-blind, so you won't know which treatment you receive. The study plans to enroll about 960 participants across multiple centers.
What's involved
If you join, you will undergo a procedure to treat your coronary artery blockage. The record does not specify the number of visits or additional tests beyond the initial procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 12 months to assess the primary outcome of target lesion failure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05946629

SELUTION 4 De Novo Small Vessel IDE Trial

Recruiting
NAAges 18+InterventionalTreatment
M.A. Med Alliance S.A.
~960 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:PCI with SELUTION SLR DCBPCI with FDA approved "-limus" DES

At a glance

Recruiting sites
68 of 70 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Target lesion failure (TLF)
Measured over 12 months
+4 more outcomes measured

Conditions

Coronary Artery Disease

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Where it's being run

70 sites across 33 states
Florida8
Texas6
Georgia5
California4
Massachusetts4
Germany4
Illinois3
Pennsylvania3

Study leadership

  • Ron Waksman, MD · PRINCIPAL_INVESTIGATOR · Medstar Health Research Institute

Who to contact

Rebecca Apruzzese
[email protected]
2016001527
Email the study team

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What this trial measures

  • Target lesion failure (TLF)12 months

    Target lesion failure (TLF) is defined as the composite of cardiac death, target-vessel myocardial infarction (MI) or clinically-driven target lesion revascularization (TLR) at 12 months. MI includes spontaneous (Type 1) MI using the 4th Universal Definition of Myocardial Infarction (UDMI) and peri-procedural MI using the Society for Cardiac Angiography and Intervention (SCAI) definition.

  • PK Sub-study Primary Endpoint 16 months

    PK parameters of C(max)

  • PK Sub-study Primary Endpoint 26 months

    PK parameters of T(max)

  • PK Sub-study Primary Endpoint 36 months

    PK parameters of AUC(last)

  • PK Sub-study Primary Endpoint 46 months

    PK parameters of MRT(last)