Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication

Not Applicable

Active, not recruiting

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

Brief 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.

Detailed 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) 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.

\*As of October 27, 2021 ChEVAS ONE Study is voluntarily closed to screening and consenting. 13 subjects enrolled in the study will continue to be observed through 5-years.

Recruitment & 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.

Arm && Interventions

Group	Intervention	Description
ChEVAS System	Chimney Endovascular Aortic Sealing (ChEVAS) System	The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms.

Primary Outcome Measures

Name	Time	Method
Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure	1-Month	The outcome at one-month post index procedure will be measured by the proportion of subjects that experience technical success and the absence of severe bowel ischemia, permanent paraplegia/paraparesis, renal failure, disabling stroke, abdominal aortic aneurysm rupture, and aneurysm-related mortality within 30-days of the index procedure.
Proportion of Safety and Effectiveness Indicators at One-Year Post-Index Procedure	1-Year	The outcome at one-year post index procedure will be measured by the proportion of subjects that experience freedom from abdominal aortic aneurysm rupture and aneurysm-related mortality up until 1-year (day 365), freedom from imaging-related findings in the 1-year window (Type 1 or 3 endoleak, migration \> 10mm, AAA sac expansion \> 5mm, and occlusion within the ChEVAS System not seen at the index procedure), and open conversion through day 365.

Secondary Outcome Measures

Name	Time	Method

Locations (8): University of Missouri
🇺🇸
Columbia, Missouri, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Valley Vascular Consultants
🇺🇸
Huntsville, Alabama, United States
MedStar Health Research Institute
🇺🇸
Washington, District of Columbia, United States
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
St Vincent Medical Group
🇺🇸
Indianapolis, Indiana, United States
Providence Portland
🇺🇸
Portland, Oregon, United States
Cooper University Hospital
🇺🇸
Camden, New Jersey, United States