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

Endoron Medical

Status: Enrolling

Conditions: Abdominal Aortic Aneurysm (AAA)

Treatments: Device: Aortoseal Endostapling System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06586021

305CLD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair with Endovascular Graft System or have a previously placed endovascular graft.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Aortoseal Endostapling System

Experimental group

Description:

Prospective, early feasibility, non-randomized, single arm, multi-center, open-label clinical study

Treatment:

Device: Aortoseal Endostapling System