Recruiting

Aortoseal™

Sponsor:

Endoron Medical

Code:

NCT06586021

Conditions

Abdominal Aortic Aneurysm (AAA)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aortoseal Endostapling System

Study Details

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.

Conditions

Abdominal Aortic Aneurysm (AAA)

Study ID

NCT06586021

Start date

Feb 6, 2024

Status verified date

Mar, 2025

Completion date

Nov 1, 2029

Anticipated

Primary completion date

Sep 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Aortoseal Endostapling System

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

Interventions

Aortoseal Endostapling System

Aortoseal Endostapling System

Primary outcome measure

  • Rate of Major Adverse Events [ Time Frame: through 5 years ]
  • Access Site Complications [ Time Frame: through 30 days ]
  • All Adverse Events [ Time Frame: through 5 years ]
  • Endpoints related to Aortoseal Endostapling System [ Time Frame: through 5 years ]
  • Device Technical Success [ Time Frame: during procedure ]

Central Contacts and Locations

Locations

Sentara Health Research Center

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Study Coordinator

757-388-2407AGANDERS@sentara.com

Principal Investigator:

Principal Investigator

More Information

Sponsor

Endoron Medical

Last update posted

Mar 12, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endoron Medical on 2025-03-12.