stAAAble Trial: Nectero EAST System for Abdominal Aortic Aneurysms - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if the Nectero EAST System® (the study procedure) is a safe and effective option for treating abdominal aortic aneurysms that are small to medium in size.

What is the Condition Being Studied?

Abdominal Aortic Aneurysm (AAA)

Who Can Participate in the Study?

Adults ages 21-85 who:

  • Are diagnosed with an AAA that is small to mid-size
  • Are able and willing to have required follow-up clinic visits including CT scans for up to 5 years

For more information, contact the study team at frank.benedetti@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, we will examine your AAA using a computerized tomography (CT) scan to see if you are right for the procedure. If you are eligible to take part, you will get a random assignment (like a coin flip) to be in the study treatment group or the control group (non-study treatment group). If you are selected for the study treatment group, you are going to have the study procedure and be followed for 5 years. If you are selected for the control group, as part of normal care, you will undergo CT scans and be followed for 5 years.

Study Details

Full Title
Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy
Principal Investigator
Vascular Surgeon
Protocol Number
IRB: PRO00114054
NCT: NCT06001918
Phase
Phase II/III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment