NCT06586021

Evaluation of the Aortoseal™ for Sealing and Fixation of AAA Endovascular Grafts to Aortic Wall

SEAL - Safety & Feasibility Evaluation of the Aortoseal™ for Seal and Fixation of Abdominal Aortic Aneurysms (AAA) Endovascular Grafts to the Aortic Wall"

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Endoron Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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, with visits at 30 days, 6 months, 1 year, and yearly thereafter through 5-years. Follow-up assessments: Physical examination, X-ray, CT (with and without contrast) and assessments of any adverse events.

Conditions

• Abdominal Aortic Aneurysm (AAA)

Interventions

Type	Name	Description
DEVICE	Aortoseal Endostapling System	Aortoseal Endostapling System

Timeline

• Start date: 2024-02-06
• Primary completion: 2029-09-01
• Completion: 2029-11-01
• First posted: 2024-09-19
• Last updated: 2025-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study