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

Not Applicable

Recruiting

• Conditions: Abdominal Aortic Aneurysm (AAA)
• Interventions: Device: Aortoseal Endostapling System

• Registration Number: NCT06586021
• Lead Sponsor: Endoron Medical

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 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.

Study Timeline

• Study Start: 2024-02-06
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-03
• Study First Posted: 2024-09-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12
• Primary Completion: 2029-09-01
• Study Completion: 2029-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aortoseal Endostapling System	Aortoseal Endostapling System	Prospective, early feasibility, non-randomized, single arm, multi-center, open-label clinical study

Primary Outcome Measures

Name	Time	Method
Rate of Major Adverse Events	through 5 years	The EFS does not have defined primary endpoints nor any powered endpoints. The SEAL Study is not hypothesis driven. All endpoints will be analyzed descriptively
Access Site Complications	through 30 days	The EFS does not have defined primary endpoints nor any powered endpoints. The SEAL Study is not hypothesis driven. All endpoints will be analyzed descriptively
All Adverse Events	through 5 years	The EFS does not have defined primary endpoints nor any powered endpoints. The SEAL Study is not hypothesis driven. All endpoints will be analyzed descriptively
Endpoints related to Aortoseal Endostapling System	through 5 years	The EFS does not have defined primary endpoints nor any powered endpoints. The SEAL Study is not hypothesis driven. All endpoints will be analyzed descriptively
Device Technical Success	during procedure	The EFS does not have defined primary endpoints nor any powered endpoints. The SEAL Study is not hypothesis driven. All endpoints will be analyzed descriptively

Trial Locations

Locations (1)

Sentara Health Research Center; 🇺🇸 Norfolk, Virginia, United States