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SELUTION 4 De Novo Small Vessel IDE Trial
NCT05946629 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 960 participants |
| Start Date | 2023-10-20 |
| Est. Completion | 2031-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05946629
The ClinicalTrials.gov registry entry for NCT05946629 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 960 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.A. Med Alliance S.A., which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05946629 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05946629?
This trial is sponsored by M.A. Med Alliance S.A., which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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