Study Details
Testing Nectero EAST in Adults with Small to Mid-Sized Abdominal Aortic Aneurysms
(IRB#: IRB_00170182)
An abdominal aortic aneurysm is an enlarged artery or tube in your belly that carries blood from your heart to the rest of the body. When the abdominal aorta enlarges the wall weakens and stretches, eventually can get big and thin enough to burst open, which can bleed and cause death. Nectro EAST is a treatment designed to slow the growth and prevent the bursting of an abdominal aortic aneurysm and may decrease the need for surgery in the future. People in the study will be required to come in for in-person clinic visits and be followed for 5 years to monitor the growth of the aneurysm. People randomly chosen to be treated with Nectro EAST will undergo a one-time 1-hour surgery. The surgery is performed through the groin and uses a balloon to deliver medication directly to the aneurysm. The balloon is removed after and recovery is very minimal. Being in the study for both groups lasts 5 years and medical tests will be done to track the health of participants.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 21 years and older
- More than 2 years of life expected
- Specific abdominal aortic aneurysm
- Able and willing to participate in all study activities
- Females must be of non-childbearing potential (menopause or sterilization)
Exclusion Criteria
- Prior surgery to repair the abdominal aortic aneurysm
- Major surgery within 30 days prior to participation
- Symptomatic abdominal aortic aneurysm
Will I be paid for my time?
Yes
IRB#: IRB_00170182
PI: Cali Johnson
Department: Vascular Surgery Division
Approval Date: 2024-03-06 07:00:00
Study Categories: Heart Studies
Specialties: Vascular Surgery