SELUTION 4 De Novo Small Vessel IDE Trial

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 2 months later Jun 2027 → Sep 2027
See other at-risk trials from M.A. Med Alliance S.A.

Record History

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  1. Enrollment closed, study ongoing Show 7 more changesShow less
    • Primary completion pushed from Jun 2027 to Sep 2027
    • Study completion pushed from Jun 2031 to Sep 2031
    • Interventions: PCI with FDA approved "-limus" DES (Device), PCI with SELUTION SLR DCB (Device) to PCI with FDA approved "-limus" DES (Device), PCI with SELUTION SLR DCB (Device)
    • Eligibility criteria expanded, about 41 words
    • Secondary endpoints: details revised at 4 of 17 entries
    • Study sites revised (70)
    • Study description expanded, about 2 words
  2. Study sites: 43 to 70v8
  3. Primary completion date: Aug 2025 to Jun 2027
    • Study sites: 27 to 43
    • Study completion date: Aug 2029 to Jun 2031
    • Eligibility criteria expanded, about 22 words
    v7
  4. Study sites: 19 to 27v6
  5. Study sites: 14 to 19
    • Collaborators expanded, about 4 words
    v5
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  1. Primary endpoints: 1 to 5v4 Show 4 more changesShow less
    • Enrollment target: 910 to 960
    • Study sites: 3 to 14
    • Eligibility criteria expanded, about 311 words
    • Secondary endpoints revised (17)
  2. Eligibility criteria expanded, about 27 words
    • Secondary endpoints: 16 to 17
    • Study description expanded, about 3 words
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 3
    • Start date changed from estimate of Jul 2023 to Oct 20, 2023
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05946629
Lead Sponsor M.A. Med Alliance S.A.
Collaborators: NAMSA, Cordis US Corp.
Conditions
(from sponsor)		 Coronary Artery Disease
Related terms Angina, Stable, Coronary Artery Disease, Non-ST Elevated Myocardial Infarction
Enrollment 960 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov