RecruitingNot Applicable

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

Brazil120 participantsStarted 2024-08-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. In one arm (including the cephalic arch) in a participant with AVF, and not in the cannulation segment, OR
✓. In the anastomosis or juxta-anastomosis in a participant with AVF (a juxta-anastomosis is defined as a location where the stent crosses the venous anastomosis)

Exclusion criteria

✕. Through the elbow
✕. In a region that causes bending of the endoprosthesis or bony protrusion over it
✕. In the cannulation segment (needling zone)
✕. Inside any part of a pre-existing stent or endoprosthesis (apart from an access arteriovenous graft)
✕. Lower extremity
✕. Non-synthetic graft
✕. Central thoracic veins located proximal to the cephalic vein arch

What they're measuring

Safety Events

Timeframe: 30 days

Target Lesion Primary Patency (TLPP)

Timeframe: 6 months

Trial details

NCT IDNCT06096142

SponsorScitech Produtos Medicos SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Luciano A Curado

+55 62 3625-5027 lcurado@scitechmed.com

View on ClinicalTrials.gov More Venous Stenosis trials