First-In-Human Study Evaluating Aneurysm Sac Lining in AAA Patients
ConditionAbdominal Aortic Aneurysm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLife Seal Vascular Inc.
About this trial
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
Eligibility criteria
Qualifiers
Patient can understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent
Patient is willing to complete the follow-up according to the requirements of the protocol.
Patient AAA anatomy complies with "instructions for use" for commercial EVAR devices used
≥18 years old
Disqualifiers
Concomitant Common Iliac Artery aneurysms ≥ 25mm
Life expectancy <2 years
Already participating in an investigational drug or device study
Known allergy or contraindication to any study device material
Trial design
Treatments tested in this trial
- Cygnum Aneurysm Sac Management Device (ASMD)
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Life Seal Vascular Inc.
Lead sponsor
Auckland City Hospital
Collaborator
Source ClinicalTrials.gov