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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

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. ;

Study Design

Related Conditions & MeSH terms

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