Using Aortoseal to improve AAA endovascular graft procedures
SEAL - Safety & Feasibility Evaluation of the Aortoseal™ for Seal and Fixation of Abdominal Aortic Aneurysms (AAA) Endovascular Grafts to the Aortic Wall"
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Endoron Medical Industry-sponsored |
| Locations | 1 site (Norfolk, Virginia) |
| Trial ID | NCT06586021 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with a qualifying AAA who are suitable for elective endovascular repair.
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.
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 performed: While similar approaches have been explored, the specific use of the Aortoseal Endostapling System in this context is novel.
Eligibility criteria
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 this trial is running
Norfolk, Virginia
- Sentara Health Research Center — Norfolk, Virginia, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.