NCT05133492

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Nectero Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase I multi-center, open-label study to evaluate use of the Nectero EAST system for stabilization of abdominal aortic aneurysms. Up to fifty (50) subjects will be treated at up to 10 worldwide sites with the device and followed for up to 36-months. Primary Study Endpoints: * Safety: absence of major events within the 1-month follow-up visit * Success: defined as successful insertion of the delivery catheter and delivery of the Stabilizer Secondary Study Endpoints: * Freedom from aneurysmal sac enlargement. Enlargement is defined as diameter increase of \>5mm per year, or aneurysm sac volume increase of \>10% per year, as assessed by CT scans at the 1, 3, (HK only), 6, 12, 24 and 36-month follow-up visits. * Aneurysm sac shrinkage, defined as diameter decrease of \>5mm, or decrease in aneurysm sac volume of \>10% as assessed by CT scans at the 1, 3 (HK only), 6, 12, 24 and 36-month follow-up visits. * Assessment of Clinical Utility Study duration is anticipated to be 6 years.

Conditions

• Abdominal Aortic Aneurysm
• AAA
• Dilation Aorta

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-24
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-11-24
• Last updated: 2025-12-16

Locations

5 sites across 5 countries: Australia, China, Colombia, Latvia, New Zealand