Status:
RECRUITING
Evaluation of the Aortoseal™ for Sealing and Fixation of AAA Endovascular Grafts to Aortic Wall
Lead Sponsor:
Endoron Medical
Conditions:
Abdominal Aortic Aneurysm (AAA)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Aortoseal Endostapling System is indicated in patients undergoing, or having undergone, treatment of an abdominal aortic aneurysm (AAA) with an endovascular graft to provide enhanced fixation and ...
Detailed Description
The device may be implanted at the time of the initial endovascular graft procedure to maintain, or during a secondary procedure to restore, adequate aneurysm. The study includes 5 years of follow-up...
Eligibility Criteria
Inclusion
- Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair with Endovascular Graft System or have a previously placed endovascular graft.
Exclusion
Key Trial Info
Start Date :
February 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06586021
Start Date
February 6 2024
End Date
November 1 2029
Last Update
March 12 2025
Active Locations (1)
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1
Sentara Health Research Center
Norfolk, Virginia, United States, 23507