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Clinical trialNCT05946629RecruitingInterventional

SELUTION 4 De Novo Small Vessel IDE Trial

SponsorM.A. Med Alliance S.A.Enrollment960Coronary Artery Disease
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

70 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Germany
  • Universitäts-Herzzentrum Freiburg

    Bad Krozingen, Germany

    Recruiting
  • Ukb Berlin

    Berlin, Germany

    Recruiting
  • Herzzentrum Dresden

    Dresden, Germany

    Recruiting
  • Mediclin Herzzentrum Lahr

    Lahr, Germany

    Recruiting
United States
  • St. Bernards

    Jonesboro, Arkansas, United States

    Recruiting
  • Cisd Sharp Chula Vista

    Chula Vista, California, United States

    Recruiting
  • Cedars Sinai

    Los Angeles, California, United States

    Recruiting
  • Hca Los Robles

    Thousand Oaks, California, United States

    Recruiting
  • Harbor Ucla

    Torrance, California, United States

    Recruiting
  • Colorado Heart and Vascular

    Golden, Colorado, United States

    Recruiting
  • Clinre

    Thornton, Colorado, United States

    Recruiting
  • Yale New Haven Hospital

    New Haven, Connecticut, United States

    Recruiting
  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, United States

    Recruiting
  • Hca Florida Jfk

    Atlantis, Florida, United States

    Withdrawn
  • Manatee Memorial

    Bradenton, Florida, United States

    Recruiting
  • Mease Countryside Hospital

    Clearwater, Florida, United States

    Recruiting
  • University of Florida, Jacksonville

    Jacksonville, Florida, United States

    Recruiting
  • Hca Largo

    Largo, Florida, United States

    Recruiting
  • Adventhealth Orlando

    Orlando, Florida, United States

    Recruiting
  • Hca Northside

    St. Petersburg, Florida, United States

    Recruiting
  • Hca Trinity

    Trinity, Florida, United States

    Recruiting
  • Atlanta Va

    Atlanta, Georgia, United States

    Recruiting
  • Emory

    Atlanta, Georgia, United States

    Recruiting
  • Piedmont Heart Institute

    Atlanta, Georgia, United States

    Recruiting
  • Hamilton Medical Center

    Dalton, Georgia, United States

    Recruiting
  • Archbold Memorial Hospital

    Thomasville, Georgia, United States

    Recruiting
  • Pali Momi Medical Center

    ‘Aiea, Hawaii, United States

    Recruiting
  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, United States

    Recruiting
  • Advocate Christ Medical Center

    Oak Lawn, Illinois, United States

    Recruiting
  • Carle Foundation Hospital

    Urbana, Illinois, United States

    Recruiting
  • University of Iowa Medical Center

    Iowa City, Iowa, United States

    Recruiting
  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas, United States

    Recruiting
  • Baptist Health Lexington

    Lexington, Kentucky, United States

    Recruiting
  • Cardiovascular Institute of the South

    Houma, Louisiana, United States

    Recruiting
  • Johns Hopkins

    Baltimore, Maryland, United States

    Withdrawn
  • University of Maryland

    Baltimore, Maryland, United States

    Recruiting
  • Beth Israel Deaconess

    Boston, Massachusetts, United States

    Recruiting
  • Brigham & Women'S

    Boston, Massachusetts, United States

    Recruiting
  • Mass General

    Boston, Massachusetts, United States

    Recruiting
  • Baystate Medical Center

    Springfield, Massachusetts, United States

    Recruiting
30 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
20 Oct 2023
Primary completion
30 Jun 2027
Completion
30 Jun 2031
Last update posted
16 Jul 2026
Registered enrollment
960
Registry id
NCT05946629
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.