GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study
NCT ID: NCT04429243
Last Updated: 2024-11-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
124 participants
OBSERVATIONAL
2020-07-02
2023-10-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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GORE® VIABAHN® Stent Graft
Participants will be examined 1, 3, 6, 12 and 24 months following the GORE® VIABAHN® Stent Graft installation.
GORE® VIABAHN® Stent Graft
On Day 1, participants will receive the GORE® VIABAHN® Stent Graft.
Interventions
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GORE® VIABAHN® Stent Graft
On Day 1, participants will receive the GORE® VIABAHN® Stent Graft.
Eligibility Criteria
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Inclusion Criteria
* Participants who was used to repair vascular access circuits for purposes other than treatment of stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Principal Investigators
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Kei Kaneko
Role: STUDY_DIRECTOR
W. L. Gore & Associates G.K
Locations
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Kaikoukai Central Clinic
Nagoya, Aichi-ken, Japan
Nagoya Vascular Access Clinic
Nagoya, Aichi-ken, Japan
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan
Kansai Rosai Hospital
Amagasaki, Hyōgo, Japan
Kanazawa Cardiovascular Hospital
Kanazawa, Ishikawa-ken, Japan
Yokohama Dai-ichi Hospital
Yokohama, Kanagawa, Japan
Japanese Red Cross Kumamoto Hospital
Higashi, Kumamoto, Japan
Saitama Medical Center
Kawagoe, Saitama, Japan
Shizuoka General Hospital
Aoi, Shizuoka, Japan
Bouseidai1 Clinic
Numazu, Shizuoka, Japan
Haruguchi Vascular Access Clinic
Chiyoda City, Tokyo, Japan
Kichijoji Asahi Hospital
Musashino, Tokyo, Japan
Vascular Access Clinic Mejiro
Toshima City, Tokyo, Japan
University of Yamanashi Hospital
Chūō, Yamanashi, Japan
Fukuoka City Hospital
Fukuoka, , Japan
Ikeda Vascular Access, Dialysis and Internal Medicine Clinic
Fukuoka, , Japan
Osaka Vascular Access Temma Nakamura Clinic
Osaka, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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JPS 19-05: AVR PMS
Identifier Type: -
Identifier Source: org_study_id