Overview
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.
Eligibility
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.