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

Abdominal Aortic Aneurysm Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• AAA
• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

• NCT number: NCT05133492
• Study type: Interventional
• Source: Nectero Medical, Inc.
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 24, 2019
• Completion date: December 31, 2026