Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

Prospective, Multicenter, Non-randomized Study With Consecutive, Eligible Subject Enrollment at Each Site, for the Evaluation of the ChEVAS System for Endovascular Repair of Paravisceral, Juxtarenal, and Pararenal Abdominal Aortic Aneurysms.

Details

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) subjects 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.

Keywords

1 Paravisceral Abdominal Aortic Aneurysm 2 Juxtarenal Abdominal Aortic Aneurysm 3 Pararenal Abdominal Aortic Aneurysm 4 Complex Abdominal Aortic Aneurysms Paravisceral Abdominal Aortic Aneurysm Juxtarenal Abdominal Aortic Aneurysm Pararenal Abdominal Aortic Aneurysm Complex Abdominal Aortic Aneurysm Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Chimney Endovascular Aortic Sealing (ChEVAS) System ChEVAS System

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • VA San Diego Healthcare System
    La Jolla California 92037 United States
  • Regents of the University of California (UCLA)
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Endologix
ID
NCT04252573
Study Type
Interventional
Participants
At least 11 people participating
Last Updated