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:
- 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
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?
Description
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
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