The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)
NCT ID: NCT06315023
Last Updated: 2025-05-11
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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RECRUITING
450 participants
OBSERVATIONAL
2023-10-06
2032-06-07
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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As Treated
All patients that have received the therapy; patients treated within and outside the IFU criteria subgroups; male and female subgroups; and duplex imaging subgroups for arterial and venous observations.
DETOUR System
Percutaneous Transmural Arterial Bypass Therapy using the DETOUR™ System
Imaging Cohort
Sites that are performing (arterial and venous) duplex ultrasound assessments according to the institution's standard practice will be asked to participate in the DUS imaging cohort. The Imaging sub-study will consist of 55 female and 55 male subjects from these sites. Duplex imaging at 1-, 12-, 24-, and 36-months post-procedure will be collected to assess the endpoints of graft patency and venous thrombus within the vein containing the graft (n=110).
DETOUR System
Percutaneous Transmural Arterial Bypass Therapy using the DETOUR™ System
Interventions
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DETOUR System
Percutaneous Transmural Arterial Bypass Therapy using the DETOUR™ System
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Fivos
UNKNOWN
Massachusetts General Hospital
OTHER
Society for Vascular Surgery Patient Safety Organization
OTHER
Endologix
INDUSTRY
Responsible Party
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Locations
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Salinas Valley Memorial Hospital
Salinas, California, United States
University of Connecticut
Storrs, Connecticut, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Delray Medical Center
Delray Beach, Florida, United States
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
NYU Langone Medical Center
New York, New York, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
University of Pennsylvania
West Chester, Pennsylvania, United States
Main Line Health
Wynnewood, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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MD
Role: primary
Other Identifiers
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CP-0029
Identifier Type: -
Identifier Source: org_study_id
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