U.S., June 14 -- ClinicalTrials.gov registry received information related to the study (NCT07020611) titled 'First-In-Human Study Evaluating Aneurysm Sac Lining in AAA Patients' on May 27.
Brief Summary: The goal of this clinical trial is to evaluate the safety and feasibility of the Cygnum Aneurysm Sac Management Device in patients with abdominal aortic aneurysms treated with endovascular aneurysm repair (EVAR). The main questions it aims to answer are:
1. Is the Cygnum device safe when used adjunctively with standard EVAR endografts?
2. Does it effectively reduce or prevent type II endoleaks by managing the aneurysm sac?
Participants will:
1. Undergo EVAR with adjunctive implantation of the Cygnum device
2. Have follow-up imaging (e...