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

Endoron Medical25 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Abdominal Aortic Aneurysm (AAA)

Interventions

Aortoseal Endostapling SystemDEVICE

Aortoseal Endostapling System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sentara Health Research Center

Norfolk, Virginia, United States

RECRUITING