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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Cygnum Aneurysm Sac Management Device (ASMD)
DeviceCygnum ASMD, adjunctive to EVAR, lines the aneurysmal wall to prevent type II endoleaks
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Cygnum ASMD ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of major adverse events (MAEs)
Rate of related major adverse events (MAEs)
Time frame
30 days post-procedure2
Procedural Technical Success
Technical success, defined as lining the AAA sac wall with the investigational devices
Time frame
Immediately after the interventionSecondary outcomes
1
Incidence of related major adverse events (MAEs)
Incidence rate of related major adverse events (MAEs)
Time frame
12 months post procedure2
Incidence of related serious adverse events (SAEs)
Incidence rate of related serious adverse events (SAEs)
Time frame
12 months post procedure3
Efficacy - Type II endoleaks
Incidence of type II endoleaks
Time frame
12 months post procedure4
Efficacy - AAA sac diameter
Change in AAA sac diameter
Time frame
12 months post procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Life Seal Vascular Inc.
Lead sponsor
Auckland City Hospital
Collaborator
Source ClinicalTrials.gov