The Solaris DE Sirolimus-Eluting Covered Stent for the Treatment of AV Access Stenosis or Occlusion

Study acronym: DEScover
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 1 month later Aug 2026 → Oct 1, 2027
See other at-risk trials from Scitech Produtos Medicos SA

Record History

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  1. Primary completion pushed from Aug 2026 to Oct 1, 2027 Show 8 more changesShow less
    • Enrollment increased: 120 → 160 participants
    • Study completion pushed from Feb 2028 to Apr 30, 2029
    • Interventions modified
    • Trial arms changed: 3 → 4
    • Study description expanded, about 40 words
    • Site details revised at 1 of 5 sites
    • Eligibility criteria expanded, about 4 words
    • Study title expanded, about 2 words
  2. Study sites: 6 to 5
    • Eligibility criteria expanded, about 86 words
    v6
  3. Site contacts updated at 6 of 6 sitesv5
  4. Site details revised at 6 of 6 sitesv4
  5. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date changed from estimate of Mar 2024 to Aug 30, 2024
    • Study sites: 0 to 6
    • Primary completion date: Mar 2026 to Aug 2026
    • Study completion date: Sep 2027 to Feb 2028
  6. Study description expanded, about 121 wordsv2
  7. 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.
The goal of this clinical trial is to demonstrate the safety and efficacy of Solaris Drug-Eluting Covered Stent (Solaris DE) in the treatment of stenosis or occlusion within the outflow circuit of the dialysis access including arteriovenous (AV) fistula and synthetic AV graft. Participants will be treated with Solaris DE. Researchers will compare the treatment with investigational product to Percutaneous Transluminal Angioplasty (PTA) alone within the AV fistula cohort in order to demonstrate superiority of Solaris DE.
Trial Details
NCT Number NCT06096142
Lead Sponsor Scitech Produtos Medicos SA
Conditions
(from sponsor)		 Venous Stenosis, Venous Occlusion, Chronic Renal Failure
Related terms Kidney Failure, Chronic
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov