Phase
Condition
Aneurysm
Heart Disease
Cardiovascular Disease
Treatment
ESAR treatment: Endograft + Heli-FX Endoanchor
FEVAR treatment : Fenestrated endograft
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is >18 years old
Subject is scheduled for primary treatment of the abdominal aortic aneurysm with anon-aneurysmal infrarenal aortic sealing zone proximal to the aneurysm that issufficiently healthy for a proximal neck length that is at least 4mm and not morethan15 mm and has a circumferential minimum sealing zone length of 8 mm
Subject is not a candidate for safe, effective and durable standard EVAR due tochallenging anatomical criteria as confirmed by the Core Lab screening
Subject is able and willing to comply with the protocol and to adhere to thefollow-up requirements.
Subject has provided written informed consent
CT Angiographic Inclusion Criteria
Subject meets the other anatomical requirements according to the locally applicableEndurant II/IIs stent graft system, Heli-FX EndoAnchor system, Terumo FenestratedAnaconda (available in EU only) and/or Cook Zenith Fenestrated Graft Instructionsfor Use
Proximal neck length of the aorta within 4-15mm and a minimum circumferentialsealing zone of 8mm
Aortic neck diameter from 19 to 31mm
Infrarenal neck angulation ≤45°
Exclusion
Exclusion Criteria:
Subject is participating in a concurrent study which may confound study results
Subject has a life expectancy <2 year
Subject is female of childbearing potential in whom pregnancy cannot be excluded
Subject with eGFR <30 mL/min/m2 (KDOQI classification - exclude class IV and above)and or on dialysis
Subject with a MI or CVA within 3 months prior to index procedure
Subject with known Connective Tissue Disease
Subject has a known hypersensitivity or contraindication to anticoagulants,antiplatelets, or contrast media, which is not amenable to post-treatment
Subject who has undergone prior endovascular or open surgical treatment forabdominal aortic aneurysm
Subject requires emergent aneurysm treatment, for example, trauma or rupture
Subject has a known hypersensitivity or allergies to study device implant material
Subject has an aneurysm that is:
Suprarenal, pararenal, or thoracoabdominal
Mycotic
Inflammatory
Pseudoaneurysm
Subject is presenting with thrombus or calcification of the proximal aneurysm neck:circumferential >50%
Pre-op stenosis of the renal arteries > 50%
Subject has active infection or history of COVID-19. History of COVID-19 is definedas availability of positive COVID-19 test with sequelae or hospitalization fortreatment of COVID-19.
Study Design
Connect with a study center
Hospital Ottakring, Institute for Vascular Surgery
Vienna, 1160
AustriaActive - Recruiting
CRC thoracic Vascular Surgery, ZOL Genk
Genk, 3600
BelgiumActive - Recruiting
Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde
Gent, 9000
BelgiumActive - Recruiting
Amrois Paré Hospital (APHP)
Boulogne,
FranceActive - Recruiting
Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert
Clermont Ferrand, 63003
FranceActive - Recruiting
Hospices Civils de lyon - Hôpital Edouard Herriot
Lyon,
FranceActive - Recruiting
Centre Hospitalier Universitaire de Rennes
Rennes,
FranceActive - Recruiting
University Hospital RWTH Aachen
Aachen, 52074
GermanyActive - Recruiting
University Hospital Leipzig
Leipzig, 04109
GermanyActive - Recruiting
University Hospital LMU Munich
Munich, 81337
GermanySite Not Available
Martin Austermann
Münster, 48145
GermanySite Not Available
University Hospital Regensburg
Regensburg, 93053
GermanySite Not Available
University of Bologna, IRCCS S. Orsola Hospital,
Bologna, 40138
ItalyActive - Recruiting
Az. Ospedaliera San Martino, Genova
Genova, 16132
ItalyActive - Recruiting
IRCCS Ospedale San Raffaele, Chirurgia Vascolare
Milano, 20132
ItalyActive - Recruiting
Vascular Endovascular Surgery University of Perugia;
Perugia, 06100
ItalySite Not Available
Az.Osped.Univers.S.Giovanni, Turin
Turin, 10154
ItalyActive - Recruiting
VUMC Amsterdam
Amsterdam,
NetherlandsSite Not Available
Catharina Ziekenhuis
Eindhoven,
NetherlandsSite Not Available
National Institute of Cardiology Warzwa
Warszawa, 04-628
PolandActive - Recruiting
Hospital Ramon Y Cajal
Madrid,
SpainActive - Recruiting
Hospital Universitario Donostia
San Sebastián,
SpainActive - Recruiting
HOSPITAL CLINICO UNIVERSITARIO Valladolid
Valladolid, 47003
SpainActive - Recruiting
Inselspital Bern, Universitätsklinik für Gefässchirurgie
Bern, 3010
SwitzerlandSite Not Available
UCSD Medical Center Hillcrest
La Jolla, California 92037
United StatesActive - Recruiting
Stanford University
Stanford, California 94305
United StatesActive - Recruiting
University of Florida
Gainesville, Florida 32608
United StatesActive - Recruiting
Corewell Health (Spectrum)
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
Mount Sinai Hospital
New York, New York 10029
United StatesActive - Recruiting
Atrium Health Carolinas Medical Center
Charlotte, North Carolina 28203
United StatesActive - Recruiting
Oklahoma Heart
Tulsa, Oklahoma 74104
United StatesActive - Recruiting
Providence Portland Medical Center
Portland, Oregon 97213
United StatesActive - Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania 14212
United StatesActive - Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United StatesActive - Recruiting
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