Status:
UNKNOWN
Safety and Efficacy of the Gore® Excluder® Iliac Branch Platform and Analysis of Its Behavior in Combination With the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (IBERVIX)
Lead Sponsor:
Asociacion para el Estudio de la Enfermedades Vasculares de Galicia
Collaborating Sponsors:
W.L.Gore & Associates
Conditions:
Aortic Aneurysm
Iliac Aneurysm
Eligibility:
All Genders
18+ years
Brief Summary
Aorto-iliac aneurysms with involvement of the iliac bifurcation or hypogastric artery aneurysms constitute only 20% of all aneurysmal pathology of the abdominal aorta. As it is a rare pathology, in or...
Detailed Description
This is a multicenter study in which 10 to 15 hospitals will participate. It is a non-intervention study in which the data from the medical records of the patients will be collected according to the a...
Eligibility Criteria
Inclusion
- Patients who have an aortoiliac aneurysm with criteria to be operated electively and who meet the anatomical criteria to be treated with the devices under study within the instructions for use.
Exclusion
- Patients who, given their anatomical characteristics, do not comply with the instructions for use of the devices under study.
- Patients with pathology at the iliac level but not aneurysmal.
- Patients who do not sign the informed consent to participate in the study
Key Trial Info
Start Date :
October 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04356313
Start Date
October 1 2019
End Date
December 31 2021
Last Update
April 22 2020
Active Locations (1)
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1
University Clinical Hospital
Santiago de Compostela, A Coruña, Spain, 15702