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

NCT ID: NCT06586021

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-06

Study Completion Date

2029-11-01

Brief Summary

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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

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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

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Abdominal Aortic Aneurysm (AAA)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aortoseal Endostapling System

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

Group Type EXPERIMENTAL

Aortoseal Endostapling System

Intervention Type DEVICE

Aortoseal Endostapling System

Interventions

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Aortoseal Endostapling System

Aortoseal Endostapling System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endoron Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sentara Health Research Center

Norfolk, Virginia, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Study Coordinator

Role: primary

757-388-2407

Other Identifiers

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305CLD

Identifier Type: -

Identifier Source: org_study_id

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