stAAAble Trial: Nectero EAST System for Abdominal Aortic Aneurysms

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.

Who Can Participate?

Eligibility

Adults ages 21-85 who:<ul>
<li>Are diagnosed with an AAA that is small to mid-size</li>
<li>Are able and willing to have required follow-up clinic visits including CT scans for up to 5 years</li></ul>
For more information, contact the study team at <a href= "mailto: frank.benedetti@duke.edu">frank.benedetti@duke.edu.</a>

Age Range

21-85

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

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

Chandler
Long

Protocol Number

PRO00114054

NCT ID

NCT06001918

Phase

II/III

Enrollment Status

Open to Enrollment
ClinicalTrials.gov