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Recruiting Not applicable Interventional

SELUTION 4 De Novo Small Vessel IDE Trial

ClinicalTrials.gov ID: NCT05946629

Public ClinicalTrials.gov record NCT05946629. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 2:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective Randomized Single-Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 PTCA Drug Eluting Balloon in the Treatment of Subjects With De Novo Coronary Lesions in Small Vessels

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05946629
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
M.A. Med Alliance S.A.
Industry
Enrollment
960 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 19, 2023
Primary completion
May 31, 2027
Completion
May 31, 2031
Last update posted
Jul 15, 2026

2023 – 2031

United States locations

U.S. sites
66
U.S. states
32
U.S. cities
58
Facility City State ZIP Site status
St. Bernards Jonesboro Arkansas 72401 Recruiting
CISD Sharp Chula Vista Chula Vista California 91911 Recruiting
Cedars Sinai Los Angeles California 90048 Recruiting
HCA Los Robles Thousand Oaks California 91360 Recruiting
Harbor UCLA Torrance California 90502 Recruiting
Colorado Heart and Vascular Golden Colorado 80401 Recruiting
ClinRe Thornton Colorado 80023 Recruiting
Yale New Haven Hospital New Haven Connecticut 06520 Recruiting
MedStar Washington Hospital Center Washington D.C. District of Columbia 20010 Recruiting
HCA Florida JFK Atlantis Florida 33462 Withdrawn
Manatee Memorial Bradenton Florida 34208 Recruiting
Mease Countryside Hospital Clearwater Florida 34695 Recruiting
University of Florida, Jacksonville Jacksonville Florida 32209 Recruiting
HCA Largo Largo Florida 33770 Recruiting
AdventHealth Orlando Orlando Florida 32803 Recruiting
HCA Northside St. Petersburg Florida 33709 Recruiting
HCA Trinity Trinity Florida 34655 Recruiting
Atlanta VA Atlanta Georgia 30033 Recruiting
Piedmont Heart Institute Atlanta Georgia 30309 Recruiting
Emory Atlanta Georgia 30322 Recruiting
Hamilton Medical Center Dalton Georgia 30720 Recruiting
Archbold Memorial Hospital Thomasville Georgia 31792 Recruiting
Pali Momi Medical Center ‘Aiea Hawaii 96701 Recruiting
Advocate Good Samaritan Hospital Downers Grove Illinois 60515 Recruiting
Advocate Christ Medical Center Oak Lawn Illinois 60453 Recruiting
Carle Foundation Hospital Urbana Illinois 61801 Recruiting
University of Iowa Medical Center Iowa City Iowa 52242 Recruiting
Cardiovascular Research Institute of Kansas Wichita Kansas 67226 Recruiting
Baptist Health Lexington Lexington Kentucky 40503 Recruiting
Cardiovascular Institute of the South Houma Louisiana 70360 Recruiting
University of Maryland Baltimore Maryland 21201 Recruiting
Johns Hopkins Baltimore Maryland 21287 Withdrawn
Beth Israel Deaconess Boston Massachusetts 02114 Recruiting
Mass General Boston Massachusetts 02114 Recruiting
Brigham & Women's Boston Massachusetts 02115 Recruiting
Baystate Medical Center Springfield Massachusetts 01199 Recruiting
Minneapolis Heart Institute Minneapolis Minnesota 55407 Recruiting
Minneapolis VA Medical Center Minneapolis Minnesota 55417 Recruiting
North Mississippi Medical Center Tupelo Mississippi 38801 Recruiting
HCA Overland Park Overland Park Missouri 66211 Recruiting
St. Louis Heart and Vascular St Louis Missouri 63136 Recruiting
University of Nebraska Omaha Nebraska 68198 Recruiting
Englewood Health Englewood New Jersey 07631 Recruiting
Icahn School of Medicine at Mount Sinai New York New York 10029 Recruiting
Stony Brook University Hospital Stony Brook New York 11794 Recruiting
NC Heart and Vascular Raleigh North Carolina 27607 Recruiting
The Lindner Research Center at Christ Cincinnati Ohio 45219 Recruiting
UH Cleveland Cleveland Ohio 44120 Recruiting
Oklahoma Heart Oklahoma City Oklahoma 73120 Recruiting
Penn State Health Hershey & Berks Hershey Pennsylvania 17033 Recruiting
UPMC Pinnacle Mechanicsburg Pennsylvania 17050 Recruiting
WellSpan York Hospital York Pennsylvania 17403 Recruiting
Lifespan Rhode Island & Miriam Providence Rhode Island 02903 Recruiting
CHI Memorial Chattanooga Tennessee 37404 Recruiting
University of Nebraska Chattanooga Tennessee 37404 Recruiting
HCA Centennial Nashville Tennessee 37203 Recruiting
Hendrick Health Abilene Texas 79601 Recruiting
Texas Health Dallas Texas 75231 Recruiting
Baylor Scott and White - Dallas Dallas Texas 75246 Recruiting
Medical City of Fort Worth Fort Worth Texas 76104 Recruiting
Baylor Scott and White Plano Plano Texas 75093 Recruiting
Baylor Scott and White - Temple Temple Texas 76508 Recruiting
Intermountain Health - Salt Lake City Murray Utah 84107 Recruiting
HCA Chippenham Richmond Virginia 23225 Recruiting
CAMC Charleston West Virginia 25304 Recruiting
Advocate Aurora St. Luke's Milwaukee Wisconsin 53215 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05946629, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 15, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05946629 live on ClinicalTrials.gov.

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