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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 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.

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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.

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

Sponsor

M.A. Med Alliance S.A.

4 total trials

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What the Registry Record Tells You About NCT05946629

The ClinicalTrials.gov registry entry for NCT05946629 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 960 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,283-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (25% lower). The listed sponsor is M.A. Med Alliance S.A., which has 4 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.