The Solaris DE Endoprosthesis for the Treatment of AV Access Stenosis or Occlusion
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.
The participant has a mature AV Fistula (AVF) or Graft (AVG) in the arm created... [+16]
Pregnant, breastfeeding or with intention to become pregnant in the next year [+28]