Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-03-31
2024-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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WRAPSODY Stent Graft
All subjects will receive treatment via WRAPSODY Stent Graft Placement.
Merit WRAPSODY Endovascular Stent Graft
Target lesion treated with stent graft placement
Interventions
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Merit WRAPSODY Endovascular Stent Graft
Target lesion treated with stent graft placement
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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ClinLogix. LLC
INDUSTRY
Merit Medical Systems, Inc.
INDUSTRY
Responsible Party
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Other Identifiers
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CVO-P3-20-01-F
Identifier Type: -
Identifier Source: org_study_id
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