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First-In-Human Study Evaluating Aneurysm Sac Lining in AAA Patients

NCT07020611 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-09

No results posted yet for this study

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.g., CT scans) and clinical assessments to evaluate device position and sac behavior over time

Conditions

  • Abdominal Aortic Aneurysm

Interventions

DEVICE

Cygnum Aneurysm Sac Management Device (ASMD)

Cygnum ASMD, adjunctive to EVAR, lines the aneurysmal wall to prevent type II endoleaks

Sponsors & Collaborators

  • Auckland City Hospital

    collaborator OTHER_GOV

  • Life Seal Vascular Inc.

    lead INDUSTRY

Principal Investigators

  • Raja Ghanem · Life Seal Vascular Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-26
Primary Completion
2026-09-30
Completion
2028-09-30
FDA Device
Yes

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07020611 on ClinicalTrials.gov