The Solaris DE Endoprosthesis for the Treatment of AV Access Stenosis or Occlusion
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: * The participant has a mature AV Fistula (AVF) or Graft (AVG) in the arm created ≥ 30 days before the initial procedure and is in use for dialysis therapy * The participant has clinical and/or hemodynamic evidence of a venous outflow obstruction or AV fistula or graft dysfunction. The stenotic lesion is ≥ 50%, with a maximum length of 8 cm and a distal reference vessel diameter from 4.0 mm to 9.0 mm * The participan provides written informed consent prior to any study-specific procedure * The participan is willing to undergo all follow-up evaluations according to the specified schedule over 24 months Angiographic Inclusion Criteria: * The target lesion originates ≥ 3 cm from the cannulation segment (needling zone) * The target lesion is located: 1. In one arm (including the cephalic arch) in a participant with AVF, and not in the cannulation segment, OR 2. In the anastomosis or juxta-anastomosis in a participant with AVF (a juxta-anastomosis is defined as a locatio