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Active (not recruiting) Not applicable NCT04252573

Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication

No applicable phase (e.g. observational)
Conditions: 1 Paravisceral Abdominal Aortic Aneurysm 2 Juxtarenal Abdominal Aortic Aneurysm 3 Pararenal Abdominal Aortic Aneurysm 4 Complex Abdominal Aortic Aneurysms

Sponsor: Endologix

trial.available_in: БГ
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) 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.
Who can participate
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.
Interventions
Chimney Endovascular Aortic Sealing (ChEVAS) System
DEVICE
Locations 8
United States (8)
Emory University
Atlanta , Georgia
Cooper University Hospital
Camden , New Jersey
University of Missouri
Columbia , Missouri
Valley Vascular Consultants
Huntsville , Alabama
St Vincent Medical Group
Indianapolis , Indiana
Icahn School of Medicine at Mount Sinai
New York , New York
Providence Portland
Portland , Oregon
MedStar Health Research Institute
Washington D.C. , District of Columbia
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
29.06.2020
Completion date
31.12.2026
Registry ID
NCT04252573
Source
clinicaltrials.gov
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