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NCT05946629 · ClinicalTrials.gov registry record · NA

SELUTION 4 De Novo Small Vessel IDE Trial

A NA study of Coronary Artery Disease, sponsored by M.A. Med Alliance S.A..

Recruiting
Registry status
NA
Development phase
960
Enrollment target
20
Study locations

NCT05946629: Recruiting NA study of Coronary Artery Disease, sponsored by M.A. Med Alliance S.A..

NCT05946629 is a NA study of Coronary Artery Disease that is actively recruiting participants, run by M.A. Med Alliance S.A.. The registered enrollment target is 960 participants, below the 1,283-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05946629, a NA study of Coronary Artery Disease, is actively recruiting participants, sponsored by M.A. Med Alliance S.A..

RECRUITING
Registry status
NA
Development phase
960 participants
Enrollment target
20
Study locations

Study Summary

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.

Primary Outcome

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.

Conditions Studied

Coronary Artery Disease

Interventions

  • DEVICE PCI with SELUTION SLR DCB
  • DEVICE PCI with FDA approved "-limus" DES

Study Locations (20)

Florida

  • HCA Florida JFK - Atlantis
  • Mease Countryside Hospital - Clearwater
  • University of Florida, Jacksonville - Jacksonville
  • HCA Largo - Largo
  • AdventHealth Orlando - Orlando

California

  • CISD Sharp Chula Vista - Chula Vista
  • Cedars Sinai - Los Angeles
  • HCA Los Robles - Thousand Oaks
  • Harbor UCLA - Torrance

Georgia

  • Atlanta VA - Atlanta
  • Piedmont Heart Institute - Atlanta
  • Emory - Atlanta
  • Archbold Memorial Hospital - Thomasville

Colorado

  • Colorado Heart and Vascular - Golden
  • ClinRe - Thornton

Illinois

  • Advocate Good Samaritan Hospital - Downers Grove
  • Advocate Christ Medical Center - Oak Lawn

Arkansas

  • St. Bernards - Jonesboro

District of Columbia

  • MedStar Washington Hospital Center - Washington D.C.

Kansas

  • Cardiovascular Research Institute of Kansas - Wichita

Trial Details

FieldValue
Enrollment Target 960 participants
Start Date 2023-10-20
Est. Completion 2031-06
Phase NA
M.A. Med Alliance S.A.

4 total trials

What NCT05946629 shows while recruiting

NCT05946629 is an interventional study that assigns participants to a tested intervention. The registered 960 participants enrollment target is mid-sized for trials with a published cap, below the 1,283-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (25% lower).

The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which PCI with SELUTION SLR DCB is the first listed.

NCT05946629 names 20 study sites across 8 states, led by Florida, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT05946629 about?

NCT05946629 is a clinical study titled "SELUTION 4 De Novo Small Vessel IDE Trial". 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-mark...

What is the current status of trial NCT05946629?

This trial is currently recruiting. It is a NA study. The enrollment target is 960 participants. The study started on 2023-10-20. Estimated completion is 2031-06.

What conditions does trial NCT05946629 study?

This clinical trial studies the following conditions: Coronary Artery Disease.

What interventions are being tested in trial NCT05946629?

The interventions under investigation include: PCI with SELUTION SLR DCB (DEVICE), PCI with FDA approved "-limus" DES (DEVICE).

Who is sponsoring clinical trial NCT05946629?

This trial is sponsored by M.A. Med Alliance S.A., which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05946629 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Coronary Artery Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05946629's enrollment target sits among peer trials

960 51st of 219 higher than 169 of 219 other Coronary Artery Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05946629

Source: ClinicalTrials.gov NCT05946629, the US trial registry maintained by the National Library of Medicine. NCT05946629 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.