SEAL - Safety & Feasibility Evaluation of the Aortoseal™ for Seal and Fixation of Abdominal Aortic Aneurysms (AAA) Endovascular Grafts to the Aortic Wall
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 apposition to the aorta.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair with Endovascular Graft System or have a previously placed endovascular graft.
Locations
United States
Virginia
Sentara Health Research Center
RECRUITING
Norfolk
Time Frame
Start Date: 2024-02-06
Estimated Completion Date: 2029-11-01
Participants
Target number of participants: 25
Treatments
Experimental: Aortoseal Endostapling System
Prospective, early feasibility, non-randomized, single arm, multi-center, open-label clinical study
Related Therapeutic Areas
Sponsors
Leads: Endoron Medical