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Активно (без набиране) Не е приложимо NCT04252573

Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication

Не е приложима фаза (напр. обсервационно)
Заболявания: 1 Paravisceral Abdominal Aortic Aneurysm 2 Juxtarenal Abdominal Aortic Aneurysm 3 Pararenal Abdominal Aortic Aneurysm 4 Complex Abdominal Aortic Aneurysms

Спонсор: Endologix

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
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.
Интервенции
Chimney Endovascular Aortic Sealing (ChEVAS) System
DEVICE
Места на провеждане 8
САЩ (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
Технически детайли
Статус
Активно (без набиране)
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
29.06.2020
Крайна дата
31.12.2026
Регистрационен номер
NCT04252573
Източник
clinicaltrials.gov
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