Nectero EAST System for Abdominal Aortic Aneurysm
This study is testing a new treatment called the Nectero EAST System for people with small to medium-sized abdominal aortic aneurysms (AAA), which are bulges in the main artery that carries blood from your heart. The treatment involves a single, local delivery of the Stabilizer Infusion Solution (drug) through a procedure. Researchers want to see if this treatment can stop the AAA from growing, compared to the usual approach of just watching it. You may be able to join if you are between 21 and 85 years old and have an AAA between 3.5 cm and 5.0 cm. The study aims to show the treatment's effectiveness over 24 months. The current recruitment status is unclear.
- Study design
- This is a randomized clinical trial planning to enroll 400 participants. It will compare the Nectero EAST System treatment to standard care.
- What's involved
- You would undergo an endovascular procedure with the Nectero EAST System and receive the Stabilizer Infusion Solution. You would have follow-up visits at 30/60 days, 6, 12, 18, and 24 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 24 months for the primary endpoint, with continued annual follow-up for up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Nectero EAST System Clinical Study
At a glance
Conditions
Where it's being run
39 sites across 28 statesStudy leadership
- Daniel Clair, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center
- Grace Wang, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
Who to contact
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What this trial measures
- Primary Endpoint24 months
The primary endpoint is the composite of all AAA-related death, rupture and repair (open-surgical, EVAR, or clinically indicated for repair as adjudicated by a committee of clinical experts blinded to the assigned arm).