stAAAble Trial: Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy
This is a prospective, randomized, controlled, multi-center, clinical trial to demonstrate efficacy of the Nectero EAST System for stabilization of abdominal aortic aneurysms with a maximum diameter of 3.5-5.0 cm.
The trial will enroll and randomize at least 400 subjects, randomized 1:1; to the Treatment arm or Control arm. All subjects will be followed at designated intervals at 30/60days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years. The purpose of this trial is to demonstrate the efficacy of the Nectero EAST System by reducing AAA clinical events of small to mid-sized aneurysms compared to current standard of care (surveillance). In addition, the study will evaluate; 1) treatment-related adverse events up to 30-days and 2) the aneurysmal growth rate over time as compared to the untreated Control arm.
The trial will enroll and randomize at least 400 subjects, randomized 1:1; to the Treatment arm or Control arm. All subjects will be followed at designated intervals at 30/60days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years. The purpose of this trial is to demonstrate the efficacy of the Nectero EAST System by reducing AAA clinical events of small to mid-sized aneurysms compared to current standard of care (surveillance). In addition, the study will evaluate; 1) treatment-related adverse events up to 30-days and 2) the aneurysmal growth rate over time as compared to the untreated Control arm.