Aortic Aneurysm Clinical Trial
Official title:
Seguridad y Eficacia de la Plataforma Gore® Excluder® Iliac Branch y análisis de su Comportamiento en Combina-ción Con la Endoprótesis GORE® VIABAHN® VBX Ba-lloon Expandable
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 order to carry out a comprehensive study of the results, it is necessary
to carry out multicenter studies to collect a considerable number of cases.
One of the most widely used devices worldwide is the GORE® EXCLUDER® Iliac Branch
Endoprosthesis, CE marked since 2013, this stent consists of two components: the iliac branch
stent and the hypogastric component (HGB), for its joint use there are instructions for use
in relation to the anatomical characteristics of the patient in order to be used.
Currently, there are other devices that can be used as a hypogastric component when the
patient's anatomy does not allow the use of HGB, one of them is: GORE® VIABAHN® VBX Balloon
Expandable Endoprosthesis, CE marked since 2017.
This study is designed to evaluate the efficacy and safety of devices with iliac branches for
the treatment of aorto-iliac aneurysms that affect the bifurcation of common iliacs, with the
use of these devices, as well as to determine the quality of life of patients after their
implantation.
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 action protocols of each center.
This is a prospective, non-randomized study where the data of the implants performed during a
12-month period will be recorded. Both the diagnosis and the follow-up of the patients to
whom the device is implanted will strictly adhere to the protocols present in each center and
which are the ones used according to all current clinical guidelines. At no time will any
intervention or diagnostic test be performed outside the protocols in force in each center.
The study does not imply any intervention or visit for the participants that is not routine
clinical practice according to the clinical-healthcare procedures of each participating
center.
Following routine clinical evaluations performed as part of standard patient care, it will be
decided, after obtaining informed consent from patients, and whether they are eligible for
the study and scheduled for the implant procedure with the devices. of the study.
After a baseline evaluation, the implant will be performed according to the usual clinical
practice of each participating center. A follow-up visit will be made 30 days, 6 and 12
months after the procedure.
Investigators will perform implant and device evaluations and document adverse events (AE)
and possible device deficiencies
Study objectives
1. Primary Objectives 1.1. General safety and efficacy at 6 months post-implant
Defined as :
- Absence of symptoms or rupture of the aneurysm.
- Growth of the aneurysm.
- Absence of reintervention.
- Need for conversion to open surgery.
- Significant clinical migration.
- Branch occlusions.
1.2 Technical success: GORE® Excluder® IBE implant in the planned location. No conversion,
death, type I or III endoleaks or obstruction of the extremity of the graft.
1.3. Safety and efficacy of IBE together with VBX compared to IBE all-in-one system at 6
months.
2 Secondary objectives 2.1. Absence of major adverse effects defined as:
- Absence of morbidity and / or mortality related to the aneurysm or the device.
- Absence of mortality from any cause.
2.2. Assessment of quality of life based on the EuroQol 5D questionnaire
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