RecruitingNot ApplicableNCT06096142

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

Prospective, Randomized, Controlled, Multicenter Study of the Solaris DE Endoprosthesis in the Treatment of Venous Outflow Stenosis or Occlusion in Hemodialysis Patients

Sponsor

Scitech Produtos Medicos SA

Enrollment

120 participants

Start Date

Aug 30, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Renal Failure Venous Stenosis Venous Occlusion

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of endoprosthesis (an internal stent-like device) called the Solaris DE to treat blockages or narrowing in the blood vessels connected to dialysis access points (arteriovenous fistulas or grafts) in patients on kidney dialysis. These blockages can stop dialysis from working properly. **You may be eligible if...** - You are on dialysis using an arteriovenous (AV) fistula or graft in your arm, established at least 30 days ago - You have evidence of a significant blockage (at least 50% narrowing, up to 8 cm long) in the outflow vein - The vessel diameter in the affected area is between 4 and 9 mm - You are willing to attend follow-up visits over 24 months **You may NOT be eligible if...** - The blockage is too close to the needle insertion zone (within 3 cm) - The blockage is in a location not suitable for the device - You have certain other vessel conditions or clotting disorders that make the procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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