Summary

Eligibility
for people ages 21-85 (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

Summary

The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.

Official Title

Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy.

Keywords

Abdominal Aortic Aneurysm, Aneurysm, Aortic Aneurysm, Nectero EAST System

Eligibility

Locations

  • San Francisco VA Medical Center
    San Francisco California 94121 United States
  • Honor Health Scottsdale Shea Medical Center
    Scottsdale Arizona 85258 United States

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
Nectero Medical, Inc.
Links
J Vasc Surg. Pilot Study
ID
NCT06001918
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 400 study participants
Last Updated