Phase
Condition
Heart Disease
Aneurysm
Cardiovascular Disease
Treatment
Chimney Endovascular Aortic Sealing (ChEVAS) System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 whichhas increased by ≥ 0.5cm within the last 6-months, or which exceeds 1.5 times thetransverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4cm willbe included
Absence of significant cranial angulation of the visceral vessels that wouldpreclude vessel cannulation and stenting
Exclusion
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 theresults of this study (patient must have completed the primary endpoint of anyprevious study at least 30-days prior to enrollment in this study)
Known allergy or contraindication to any device material, contrast, oranticoagulants
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 mayinterfere with delivery system introduction or stent placement
Connective tissue diseases (e.g., Marfan Syndrome)
Unsuitable vascular anatomy that may interfere with device introduction ordeployment
Pregnant, planning to become pregnant within 60 months, or breast feeding.
Study Design
Study Description
Connect with a study center
Valley Vascular Consultants
Huntsville, Alabama 35801
United StatesSite Not Available
Phoenix Cardiovascular Research
Phoenix, Arizona 85018
United StatesSite Not Available
VA San Diego Healthcare System
La Jolla, California 92037
United StatesSite Not Available
Regents of the University of California (UCLA)
Los Angeles, California 90095
United StatesSite Not Available
UC Health- Memorial Hospital
Colorado Springs, Colorado 80909
United StatesSite Not Available
MedStar Health Research Institute
Washington, District of Columbia 20010
United StatesSite Not Available
Baptist Hospital of Miami
Miami, Florida 33176
United StatesSite Not Available
Advent Health Orlando
Orlando, Florida 32803
United StatesSite Not Available
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
St Vincent Medical Group
Indianapolis, Indiana 46260
United StatesSite Not Available
University of Maryland
Baltimore, Maryland 21201
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
McLaren Bay Region
Bay City, Michigan 48708
United StatesSite Not Available
University of Missouri
Columbia, Missouri 65212
United StatesSite Not Available
Midwest Aortic & Vascular Institute (MAVI)
North Kansas City, Missouri 64116
United StatesSite Not Available
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03766
United StatesSite Not Available
Cooper University Hospital
Camden, New Jersey 08103
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10019
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Providence Portland
Portland, Oregon 97213
United StatesSite Not Available
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
Wellmont CVA Heart Institute
Kingsport, Tennessee 37660
United StatesSite Not Available
Cardiovascular Surgery Clinic
Memphis, Tennessee 38120
United StatesSite Not Available
Inova Fairfax
Falls Church, Virginia 22042
United StatesSite Not Available
Sentara Vascular Specialists
Norfolk, Virginia 23507
United StatesSite Not Available

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