NCT06096142

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Scitech Produtos Medicos SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, randomized (1:1), controlled, multicenter study to investigate the safety and efficacy of the Solaris DE Endoprosthesis in the treatment of hemodialysis patients with stenosis or occlusion of the venous outflow circuit. The study population includes two cohorts: * AVF cohort: participants presenting an arteriovenous fistula (AVF) stenosis or occlusion of the peripheral venous outflow circuit, including the cephalic arch, will be randomized 1:1 between treatment with the test device (Solaris DE) or standard treatment by Percutaneous Transluminal Angioplasty (PTA) alone); * AVG cohort: participants with an arteriovenous graft (AVG) presenting stenosis or occlusion at the graft vein anastomosis or juxta-anastomosis or at the segment of the prosthesis exit circuit, will be treated with the test device (Solaris DE) only.

Conditions

• Venous Stenosis
• Venous Occlusion
• Chronic Renal Failure

Interventions

Type	Name	Description
DEVICE	Solaris DE	Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE implantation in the treated vessel.
DEVICE	PTA	Percutaneous Transluminal Angioplasty (PTA) in the treated vessel alone.

Timeline

• Start date: 2024-08-30
• Primary completion: 2026-08-01
• Completion: 2028-02-01
• First posted: 2023-10-23
• Last updated: 2026-03-17

Locations

5 sites across 1 country: Brazil