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ACTIVE NOT RECRUITING
NCT05133492
NA

First In Human Study for Small to Medium-sized Abdominal Aortic Aneurysm (AAA)

Sponsor: Nectero Medical, Inc.

View on ClinicalTrials.gov

Summary

This is a first in human study to evaluate the safety and clinical utility of an investigational medical device called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA.

Official title: A Clinical Pilot Study to Evaluate the Safety and Clinical Utility of The Nectero EAST System for Stabilization of Abdominal Aortic Aneurysms

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2019-06-24

Completion Date

2026-12-31

Last Updated

2025-12-16

Healthy Volunteers

Yes

Interventions

DEVICE

Endovascular Aneurysm Stabilization Treatment (EAST)

Endovascular procedure: an ipsilateral ilio-femoral aortogram to confirm suitability for placement of a 14F sheath will be performed. A baseline contrast aortogram will be performed to assess vessel patency and target location of the EAST delivery catheter. Occluding and Stabilizer balloons are inflated in preparation for Stabilizer Compound delivery within the AAA sac. A post-Stabilizer angiogram will re-assess vessel patency and aorta stability. Delivery catheter is removed and discarded. The entire procedure is approximately one hour.

Locations (5)

Prince of Wales Private Hospital

Randwick, New South Wales, Australia

Queen Mary Hospital

Hong Kong, Southern District, China

Pablo Tabon Uribe Hospital

Medellín, Antioquia, Colombia

Pauls Stradins Clinical University Hospital

Riga, Latvia

Auckland City Hospital

Auckland, New Zealand