Phase
Condition
Heart Disease
Aneurysm
Cardiovascular Disease
Treatment
Endurant Chimney Graft Technique
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 juxtarenal aortic aneurysm with ashort infrarenal neck (i.e. no revision subjects)
Subject is able and willing to comply with the protocol and to adhere to thefollow-up requirements
Subject has provided written informed consent
Subject is an eligible candidate according to the currently available EndurantII/IIs instructions for use for ChEVAR
Subject has a juxtarenal aortic aneurysm with a short infrarenal neck (definition ofjuxtarenal aortic aneurysm with a short infrarenal neck will be in accordance withcommercially available Endurant II/IIs instructions for use for ChEVAR).
Exclusion
Exclusion Criteria:
Subject is participating in a concurrent study which may confound study results
Subject has a life expectancy ≤ 2 year
Subject has an aneurysm that is:
Suprarenal or pararenal
Isolated iliofemoral
Mycotic
Inflammatory
Pseudoaneurysm
Subject requires emergent aneurysm treatment, for example, trauma or rupture
Subject has previously undergone surgical treatment for abdominal aortic aneurysm
Subject is a female of childbearing potential in whom pregnancy cannot be excluded
Subject has a known hypersensitivity or contraindication to anticoagulants,anti-platelets, or contrast media, which is not amenable to pre-treatment
Subject has a creatinine level >2.0 mg/dl (or >176.8 μmol/L) and/or is on dialysis
Subject has an active COVID-19 infection or relevant history of COVID-19. Relevanthistory of COVID-19 is defined as availability of a positive COVID-19 test withsequela or hospitalization for treatment of COVID-19. Subjects with a positiveCOVID-19 test who were asymptomatic or had mild symptoms should be excluded only ifthe positive test was less than 6 months prior to enrollment
Study Design
Connect with a study center
Ordensklinikum Linz GmbH / Elisabethinen
Linz, 4010
AustriaSite Not Available
CHU de Bordeaux - Centre Universitaire Pellegrin
Bordeaux, 33000
FranceSite Not Available
Hôpitaux Universitaires Paris Ile-de-France Ouest - Hôpital Ambroise-Paré
Boulogne Billancourt, 92104
FranceSite Not Available
Klinikum Chemnitz gGmbH
Chemnitz, 09116
GermanySite Not Available
Elisabeth Krankenhaus Essen GmbH
Essen, 45138
GermanySite Not Available
Universitäts Klinikum Frankfurt - Goethe-Universität
Frankfurt am Main, 60590
GermanySite Not Available
Universitätsklinikum Heidelberg
Heidelberg, 69120
GermanySite Not Available
Krankenhaus Porz am Rhein gGmbH
Köln, 51149
GermanySite Not Available
St. Franziskus-Hospital Münster GmbH
Münster, 48145
GermanySite Not Available
Evaggelismos General Hospital of Athens
Athens, 106 76
GreeceSite Not Available
University Hospital of Larissa
Larissa, 413 34
GreeceSite Not Available
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, 546 42
GreeceSite Not Available
Galway Clinic
Galway, H91 HHTO
IrelandSite Not Available
Galway University Hospitals - University Hospital Galway (UHG)
Galway, H91 YR71
IrelandSite Not Available
Azienda Ospedaliera di Cosenza
Cosenza, 87100
ItalySite Not Available
Ospedale Civile Sant'Andrea
La Spezia, 19124
ItalySite Not Available
Azienda Ospedaliera San Camillo Forlanini - Ospedale San Camillo
Roma, 00152
ItalySite Not Available
Stichting Rijnstate Ziekenhuis
Arnhem, 6815
NetherlandsSite Not Available
Medisch Spectrum Twente
Enschede, 7512 KZ
NetherlandsSite Not Available
Zuyderland Medisch Centrum
Heerlen, 6419PC
NetherlandsSite Not Available
Hospital de Santa Marta
Lisboa, 1169-024
PortugalSite Not Available
Russian Cardiologic Research and Production Complex, Russian Ministry of Health
Moscow, 121552
Russian FederationSite Not Available
CINRE s.r.o.
Bratislava, 85105
SlovakiaSite Not Available
Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
Bratislava 37, 83348
SlovakiaSite Not Available
Hospital Clinic de Barcelona
Barcelona, 08036
SpainSite Not Available
Corporacío Parc Taulí - Hospital de Sabadell
Sabadell, 08208
SpainSite Not Available
Skånes Universitetssjukhus Malmö
Malmö, 205 02
SwedenSite Not Available
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011
SwitzerlandSite Not Available
UniversitätsSpital Zürich
Zürich, 8091
SwitzerlandSite Not Available
St George's University Hospitals - NHS Trust
London, SW17 0QT
United KingdomSite Not Available
Central Manchester University Hospitals NHS - Manchester Royal Infirmary
Manchester, M13 9WL
United KingdomSite Not Available
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