Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy.
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.
• 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.
• Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 130 mm.
• Iliac and femoral artery access, vessel size and morphology allow endovascular access of 14F (or larger) introducer sheaths and catheters.
• Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria, inclusive.
• Subject has \> three-year life expectancy.
• Subject is able and willing to comply with all required follow-up clinic visits including CT scans (pre-randomization, 6, 12, 18, 24 months and annually up to 5 years) and blood draws.