Pilot Study to Test Safety and Effectiveness of Retreatment Using the Nectero EAST System for Abdominal Aortic Aneurysm Stabilization

What this Trial Is About

Researchers are evaluating the safety and usefulness of retreating Abdominal Aortic Aneurysms AAA using an investigational combination product called the Nectero EAST System. This exploratory pilot study focuses on participants who have previously received initial treatment with this system. The study aims to assess technical success, adverse events within 30 days, and aneurysm growth over 12 and 24 months after retreatment. Participants undergo a one-time endovascular procedure where the Nectero EAST System delivers a Stabilizer Infusion Solution directly into the aneurysm sac. This device is placed inside the aneurysm through blood vessels, using a catheter and introducer sheath. The treatment period includes the initial procedure and follow-up visits extending up to 24 months. During the study, participants will have clinic visits that include CT scans and blood draws at screening, 6, 12, and 24 months. Researchers will monitor the technical success of the treatment, any adverse events, and changes in the aneurysm size over time. The study requires participants to commit to these follow-up visits and assessments to evaluate the long-term impact of the retreatment with the Nectero EAST System.

Nectero EAST System Retreatment Study