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

Part of paid clinical trials in Norfolk, Virginia.

Sponsor: Endoron Medical
Study ID: NCT06586021
Status: Recruiting

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Conditions

Abdominal Aortic Aneurysm (AAA)

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Aortoseal Endostapling System — DEVICE
Aortoseal Endostapling System

Study Details

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.

Key Dates

Start date: Feb 6, 2024
Status verified: Mar 2025
Primary completion: Sep 1, 2029
Completion: Nov 1, 2029

Study Design

Enrollment: 25 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Aortoseal Endostapling System
Prospective, early feasibility, non-randomized, single arm, multi-center, open-label clinical study

Primary Outcome Measure

Rate of Major Adverse Events [ Time Frame: through 5 years ]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Sentara Health Research Center	Norfolk	Virginia	23507	Study Coordinator [email protected] 757-388-2407 Principal Investigator (PRINCIPAL_INVESTIGATOR)

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Sentara Health Research Center· Norfolk, VA