Prospective, Randomized, Controlled, Multicenter Study of the Solaris DE Endoprosthesis in the Treatment of Venous Outflow Stenosis or Occlusion in Hemodialysis Patients
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 ≥ 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 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:
‣ 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)
• The target lesion includes a de novo stenotic lesion or restenosis
• The target lesion is ≥ 5 cm from the arterial anastomosis
• The target lesion has ≥ 50% stenosis according to the operator's visual judgment
• The reference vessel diameter of the target lesion is between 4.0 mm and 9.0 mm by the operator's visual judgment
• Single or multiple target lesions measuring ≤ 8 cm in total length by the operator's visual judgment
• Single or multiple target lesions should be covered by a single stent or multiple overlapping stents, provided they are treated as a single lesion with a maximum length of 8 cm
• Successful target lesion pre-dilatation is defined as crossover of the guidewir resulting in full expansion of the pre-dilatation balloon
• The participant has up to 1 (one) non-target lesion in the venous outflow circuit requiring intervention in the initial procedure. The non-target lesion must be at least 10 cm away from the target lesion. The non-target lesion can only be treated with standard PTA alone
• Does not have stent implanted or it has been in the access circuit for ≥ 30 days since placement and patent with ≤ 30% stenosis and located ≥ 5 cm from the target lesion
• The non-target lesion must be successfully treated at the time of the initial procedure (success measured as ≤30% residual stenosis and no complications).