Clinical Trial

The Solaris DE Endoprosthesis for the Treatment of AV Access Stenosis or Occlusion

Study acronym: DEScover
Recruiting
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Summary
The goal of this clinical trial is to demonstrate the safety and efficacy of Solaris DE Endoprosthesis 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 Endoprosthesis. 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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-10-17; most recent amendment 2026-03-13.
Status change: Not Yet Recruiting → Recruiting 2024-09-02
Trial Details
NCT Number NCT06096142
Lead Sponsor Scitech Produtos Medicos SA
Conditions Venous Stenosis, Venous Occlusion, Chronic Renal Failure
Enrollment 120 participants
Start Date 2024-08-30
Primary Completion 2026-08 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2026-03-17