Using Aortoseal to improve AAA endovascular graft procedures
Official title: SEAL - Safety & Feasibility Evaluation of the Aortoseal™ for Seal and Fixation of Abdominal Aortic Aneurysms (AAA) Endovascular Grafts to the Aortic Wall"
Run by Endoron Medical · NCT06586021 · Data updated 2026-11-12
This study is testing a new device called Aortoseal to see if it can help improve the way doctors attach grafts during surgery for people with abdominal aortic aneurysms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Endoron Medical Industry-sponsored |
| Locations | 1 site (Norfolk, Virginia) |
| Status | Recruiting |
| Started | February 6, 2024 |
| Main results expected | September 1, 2029 |
| Study ends | November 1, 2029 |
| Registry record updated | March 12, 2025 |
| Trial ID | NCT06586021 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients diagnosed with a qualifying AAA who are suitable for elective endovascular repair.
✕Probably not a fit
Patients who do not have a qualifying AAA or those who have not undergone endovascular graft placement may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the Aortoseal Endostapling System, which is designed to enhance the fixation and apposition of endovascular grafts to the aortic wall in patients with abdominal aortic aneurysms (AAA). The device can be implanted during the initial graft procedure or during a secondary procedure to restore adequate aneurysm support. Participants will be followed for five years with regular assessments including physical exams and imaging studies to monitor outcomes and any adverse events.
Why it matters
Potential benefit: If successful, this approach could lead to improved outcomes and reduced complications for patients undergoing AAA repair.
How similar studies have gone: While similar approaches have been explored, the specific use of the Aortoseal Endostapling System in this context is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair with Endovascular Graft System or have a previously placed endovascular graft.
Where it's running
-
Sentara Health Research Center
Norfolk, Virginia, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.