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First In Human Study for Small to Medium-sized Abdominal Aortic Aneurysm (AAA)
Sponsor: Nectero Medical, Inc.
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
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