The Merit WRAPSODY Central Feasibility Study

Launched by MERIT MEDICAL SYSTEMS, INC. · Sep 1, 2020

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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.