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

Inclusion Criteria:

• The participant has a mature AV Fistula (AVF) or Graft (AVG) in the arm created ≥ 30days before the initial procedure and is in use for dialysis therapy

• The participant has clinical and/or hemodynamic evidence of a venous outflowobstruction or AV fistula or graft dysfunction. The stenotic lesion is ≥ 50%, with amaximum 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-specificprocedure

• The participan is willing to undergo all follow-up evaluations according to thespecified 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 inthe cannulation segment, OR

2. In the anastomosis or juxta-anastomosis in a participant with AVF (ajuxta-anastomosis is defined as a location where the stent crosses the venousanastomosis)

• 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 bythe operator's visual judgment

• Single or multiple target lesions measuring ≤ 8 cm in total length by the operator'svisual judgment

• Single or multiple target lesions should be covered by a single stent or multipleoverlapping stents, provided they are treated as a single lesion with a maximumlength of 8 cm

• Successful target lesion pre-dilatation is defined as crossover of the guidewirresulting in full expansion of the pre-dilatation balloon

• The participant has up to 1 (one) non-target lesion in the venous outflow circuitrequiring intervention in the initial procedure. The non-target lesion must be atleast 10 cm away from the target lesion. The non-target lesion can only be treatedwith standard PTA alone

• Does not have stent implanted or it has been in the access circuit for ≥ 30 dayssince placement and patent with ≤ 30% stenosis and located ≥ 5 cm from the targetlesion

• The non-target lesion must be successfully treated at the time of the initialprocedure (success measured as ≤30% residual stenosis and no complications).

Exclusion Criteria:

• Pregnant, breastfeeding or with intention to become pregnant in the next year

• The participant has any major endovascular or surgical procedure planned (includingin the access circuit) within 30 days of the initial procedure

• It was not possible to pre-dilate the lesion to be treated with Solaris DE

• Planned surgical revision of the access site

• Known or suspected infection of the hemodialysis access site, systemic infectionand/or sepsis

• Patients on immunosuppressive therapy

• Known active coagulopathy or bleeding diathesis

• Known hypersensitivity to nickel titanium alloy, contrast or sirolimus

• Contraindication to antiplatelet, anticoagulant or thrombolytic therapies

• Known allergy to contrast agents or medications administered to perform endovascularintervention that cannot be adequately premedicated

• Life expectancy of less than 12 months

• Has a stent or endoprosthesis located anywhere in the AV access circuit that is notpatent (> 30% stenosis) or implanted < 30 days

• The participant's hemodialysis access is expected to be abandoned within 6 months

• The participantis is enrolled in another trial involving an investigational product (pharmaceutical, biological or medical device)

Angiographic Exclusion Criteria:

• The target lesion is located inside an endoprosthesis

• Target lesion treatment would involve the cannulation segment (needling zone)

• The target lesion is < 5 cm from the arterial anastomosis

• Evidence of an aneurysm, pseudoaneurysm or acute thrombus (i.e. one that has beentreated ≤ 15 days) within the target lesion

• The target lesion is, and/or Solaris DE would be placed anywhere:

1. Through the elbow

2. In the cannulation segment (needling zone)

3. Inside any part of a pre-existing stent or endoprosthesis (apart from an accessarteriovenous graft)

4. Lower extremity

5. Non-synthetic graft

• The target lesion is located in such a way that the insertion of a stent wouldresult in a "kink" area that requires a stent bridge between the Solaris DE and anexisting stent or stent graft

• The individual has more than 1 (one) non-target lesion (≥ 50% stenosis) thatrequires intervention in the initial procedure