Phase
Condition
Heart Disease
Aneurysm
Cardiovascular Disease
Treatment
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as aBridging Stent in conjunction with a branched/fenestrated stent graft to allowendovascular aneurysm repair from 31 December 2021 until 01 January 2017
Age ≥18 years at the time of implant
Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at registry entry, unless a waiver was granted), according tolocal regulations.
Exclusion
Exclusion Criteria:
Patient treated for ruptured aneurysm or who were otherwise hemodynamically unstableat the time of the procedure
Patient treated for acute or sub-acute dissection, <90 days from onset of symptoms
Patient treated using physician-modified endovascular grafts
Patient intended to be treated with chimney, periscope, octopus, sandwich techniqueper the pre-treatment case plan
At the time of treatment, patient had known coagulation disorders includinghypercoagulability that were not amenable to treatment
Patient was pregnant at the time of treatment.
Participation in another drug or device investigational study within one year ofdevice implant, that can confound the registry endpoints.
Patient had known or suspected systemic infection (including treatment for mycoticaneurysm) at the time of implant.
Study Design
Study Description
Connect with a study center
Aarhus University
Aarhus, 8200
DenmarkSite Not Available
Rigshospitalet
Copenhagen, 2100
DenmarkSite Not Available
IRCCS Ospedale Policlinico San Martino
Genova, 16132
ItalySite Not Available
"Vita-Salute" San Raffaele University I.R.C.C.S Ospedale San Raffaele
Milano, 20132
ItalySite Not Available
Azienda Ospedaliera Complesso Ospedaliero San Giovanni Addolorata
Roma, 00184
ItalySite Not Available
Azienda Ospedaliera Universitaria Policlinico Umberto I
Roma,
ItalySite Not Available
AMC, Meibergdreef 9
Amsterdam, 1105
NetherlandsSite Not Available
Haukeland Universitetssjukehus
Bergen, 5021
NorwaySite Not Available
UNN Tromsø
Tromsø, 9038
NorwaySite Not Available
St. Olavs Hospital
Trondheim,
NorwaySite Not Available
Hospital Clínico Universitario San Cecilio
Granada, 18016
SpainSite Not Available
Hospital Clinico San Carlos
Madrid, 28040
SpainSite Not Available
Skane University Hospital
Malmö, 214 28
SwedenSite Not Available
Uppsala University Hospital
Uppsala, S-751 85
SwedenSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.