Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication

Running, not enrolling · Not applicable

Conditions studied: 1 Paravisceral Abdominal Aortic Aneurysm, 2 Juxtarenal Abdominal Aortic Aneurysm, 3 Pararenal Abdominal Aortic Aneurysm, 4 Complex Abdominal Aortic Aneurysms

In brief

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.

Key facts

Study ID

NCT04252573

Run by

Endologix

People needed

13

Starts

2020-06-29

Expected to finish

2026-12-31

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Valley Vascular Consultants — Huntsville, Alabama, United States
• MedStar Health Research Institute — Washington D.C., District of Columbia, United States
• Emory University — Atlanta, Georgia, United States
• St Vincent Medical Group — Indianapolis, Indiana, United States
• University of Missouri — Columbia, Missouri, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Providence Portland — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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