Post-Market Registry in Europe and US for the Use of VascuCelTM
NCT ID: NCT04906824
Last Updated: 2025-03-10
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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ACTIVE_NOT_RECRUITING
100 participants
OBSERVATIONAL
2023-06-09
2026-09-30
Brief Summary
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Detailed Description
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* Great vessel reconstruction
* Peripheral vascular reconstruction
As suture line buttressing is a procedure that does not consistently use tissue, data on this indication will only be included if available. Data will be prospectively collected by the sites on registry-specific electronic case report forms (eCRFs). The primary endpoints will assess device's safety and performance through measures and images obtained via the facility's standard of care at the respective registry site. Additional data will also be collected from the implant procedure to assess user (surgeon) satisfaction with the devices' handling and performance.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
VascuCel implantation in order to perform great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
Eligibility Criteria
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Inclusion Criteria
* patient is a candidate for treatment with VascuCel per approved device indications.
ALL
No
Sponsors
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Avania
INDUSTRY
LeMaitre Vascular
INDUSTRY
Responsible Party
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Principal Investigators
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Ioana Ghiu
Role: STUDY_DIRECTOR
Anteris
Locations
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Kootenai Health
Coeur d'Alene, Idaho, United States
Eddy Luh
Las Vegas, Nevada, United States
Westchester Medical Center
Valhalla, New York, United States
University North Carolina
Chapel Hill, North Carolina, United States
ASST Sette Laghi Varese
Varese, , Italy
Countries
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Other Identifiers
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GLRA-G011
Identifier Type: -
Identifier Source: org_study_id
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