Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)

Inclusion Criteria:

1. Subject provides written informed consent for study participation.

2. Subject is male or female, with an age ≥ 18 years at date of enrollment.

3. Subject is willing to comply with site standard of care procedures and follow-upvisit schedules over 24 months.

4. Subject is undergoing chronic hemodialysis with the hemodialysis access theintervention will be performed upon

5. The dialysis access is considered mature and has been used to deliver hemodialysistreatments for at least one session.

6. Subject has stenosis or occlusion within the dialysis outflow circuit of anarteriovenous (AV) fistula or AV graft and is treated with WRAPSODY EndoprosthesisSystem in accordance with device instructions for use.

Exclusion Criteria:

1. Subject has a planned surgical revision of access site.

2. Subject has a known or suspected infection of the hemodialysis access site, systemicinfection and/or septicemia.

3. Subject has an uncorrectable coagulation disorder.

4. Known hypersensitivity to nickel titanium alloy.

5. Subject's hemodialysis access is anticipated to be abandoned within 6 months.

6. Subject is scheduled for kidney transplant or peritoneal dialysis within the next 6months post-procedure.

7. Full expansion of a Percutaneous Transluminal Angioplasty (PTA) balloon cannot beachieved during predilatation.

8. Device would be placed in the Superior Vena Cava

9. Any inflow or outflow lesion that could jeopardize patency access long-term beyondthe target treatment area.