Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication

  • STATUS
    Recruiting
  • End date
    Mar 28, 2028
  • participants needed
    120
  • sponsor
    Endologix
Updated on 19 February 2024

Summary

Prospective, multi-center, non-randomized study with consecutive, eligible subject enrollment at each site, for the evaluation of the ChEVAS System for Endovascular Repair of Complex Abdominal Aortic Aneurysms.

Description

This is a prospective multicenter study with consecutive eligible subject enrollment at each site. Enrollment will include up to 150 subjects (120 ChEVAS subjects and up to 30 infrarenal roll-in subjects). The ChEVAS study will evaluate the safety and effectiveness outcomes following appropriate government and ethics committee/IRB requirements and guidelines.

All enrolled (ChEVAS and Infrarenal) patients will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30-days, 6-months, and annually to 5-years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.

Details
Condition 1 Paravisceral Abdominal Aortic Aneurysm, 2 Juxtarenal Abdominal Aortic Aneurysm, 3 Pararenal Abdominal Aortic Aneurysm, 4 Complex Abdominal Aortic Aneurysms
Age 18years - 100years
Treatment Chimney Endovascular Aortic Sealing (ChEVAS) System
Clinical Study IdentifierNCT04252573
SponsorEndologix
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults at least 18-years old
Subject provided informed consent
Subject agrees to all follow-up visits
Abdominal aortic aneurysm (AAA) with maximum sac diameter 5.0 cm, or 4.5 cm which has increased by 0.5cm within the last 6-months, or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4cm will be included
Absence of significant cranial angulation of the visceral vessels that would preclude vessel cannulation and stenting

Exclusion Criteria

Requirement of home oxygen
Psychiatric or other condition that may interfere with the study
Participating in another clinical drug and/or device study, which could confound the results of this study (patient must have completed the primary endpoint of any previous study at least 30-days prior to enrollment in this study)
Known allergy or contraindication to any device material, contrast, or anticoagulants
Serum creatinine level >1.8mg/dL
CVA or MI within three months of enrollment/treatment
Prior stent in any target visceral vessel, the aorta or iliac artery that may interfere with delivery system introduction or stent placement
Connective tissue diseases (e.g., Marfan Syndrome)
Unsuitable vascular anatomy that may interfere with device introduction or deployment
Pregnant, planning to become pregnant within 60 months, or breast feeding
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