Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication (ChEVAS One)

Endologix

Status: Active, not recruiting

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

Treatments: Device: Chimney Endovascular Aortic Sealing (ChEVAS) System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04252573

CP-0015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

ChEVAS System

Experimental group

Description:

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.

Treatment:

Device: Chimney Endovascular Aortic Sealing (ChEVAS) System