Nectero EAST System Clinical Study
ConditionAbdominal Aortic Aneurysm
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age21-85
SponsorNectero Medical, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Males and females ≥21 to ≤85 years of age. Females must be of non-childbearing potential (menopause or sterilization).
Subject understands the purpose of the trial, agrees to voluntarily participate in the trial, signs the informed consent and is willing to complete the follow-up according to the requirements of the protocol.
Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female).
Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
Disqualifiers
Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm.
Subject has a symptomatic infrarenal abdominal aortic aneurysm.
Subject has a mycotic or infected aneurysm.
Subject has current vascular injury due to trauma.
Trial design
Treatments tested in this trial
- Nectero EAST System
Treatment groups
400 Participants
are divided into 2 treatment groupsLocations
39Australia
Prince of Wales Private Hospital- POW Vascular Institute2031, RandwickNew South Wales, Australia
New Zealand
Auckland City Hospital1023, Auckland New Zealand
United States
Arizona
Honor Health Scottsdale Shea Medical Center85258, Scottsdale United States
Colorado
University of Colorado80045, Aurora United States
Sponsors and collaborators
Nectero Medical, Inc.
Lead sponsor
Source ClinicalTrials.gov