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.g., CT scans) and clinical assessments to evaluate device position and sac behavior over time
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Cygnum ASMD, adjunctive to EVAR, lines the aneurysmal wall to prevent type II endoleaks
Auckland City Hospital
Auckland, New Zealand
RECRUITINGIncidence of major adverse events (MAEs)
Rate of related major adverse events (MAEs)
Time frame: 30 days post-procedure
Procedural Technical Success
Technical success, defined as lining the AAA sac wall with the investigational devices
Time frame: Immediately after the intervention
Incidence of related major adverse events (MAEs)
Incidence rate of related major adverse events (MAEs)
Time frame: 12 months post procedure
Incidence of related serious adverse events (SAEs)
Incidence rate of related serious adverse events (SAEs)
Time frame: 12 months post procedure
Efficacy - Type II endoleaks
Incidence of type II endoleaks
Time frame: 12 months post procedure
Efficacy - AAA sac diameter
Change in AAA sac diameter
Time frame: 12 months post procedure
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