Nectero EAST System Clinical Study
Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy.
Nectero Medical, Inc.
400 participants
Oct 25, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Treated subjects will undergo an endovascular procedure with the Nectero EAST system and receive the Stabilizer Infusion Solution (drug) within 30 days of the study eligibility by CT scan as a one-time local delivery of the drug.
Locations(39)
View Full Details on ClinicalTrials.gov
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NCT06001918