The Merit WRAPSODY Central Feasibility Study

Inclusion Criteria: * Subject provides written informed consent * Subject is male or female, with an age ≥ 18 years at date of enrollment. * Subject is willing to undergo all follow-up assessments. * Subject has a life expectancy ≥ 12 months. * Subject is undergoing chronic hemodialysis. * Subject has either a mature AVF or AVG in the arm. * Target lesion(s) involves a non-stented restenotic lesion. * Target lesion has ≥50% stenosis. * Target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm Exclusion Criteria: * Subject is unable or is unwilling to comply with the procedural requirements of the study protocol. * Subject has a comorbidity that in the investigator's opinion would limit life expectancy to less than 12 months. * Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia. * Subject has a stroke diagnosis within 3 months prior to enrollment. * Subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment. * Subject is pregnant, breastfeeding, or intending to become pregnant within the next year. * Target lesion is located within a stent / stent graft.