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)
IBERVIX
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
1 other identifier
observational
100
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 19, 2020
CompletedFirst Posted
Study publicly available on registry
April 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedApril 22, 2020
April 1, 2020
1.3 years
April 19, 2020
April 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
General safety and efficacy at 6 months post-implant
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
6 months
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 year
Safety and efficacy
IBE together with VBX compared to IBE all-in-one system
6 months
Secondary Outcomes (2)
Absence of major adverse effects
6 months
Assessment of quality of life
6 months
Study Arms (2)
GORE® EXCLUDER® Iliac Branch Endoprosthesis & HGB
Patients with Aorto-Iliac Aneurysm with implantation of a Iliac Branch device (IBE) and the Hipogastric component (HGB)
GORE® EXCLUDER® Iliac Branch Endoprosthesis & VBx
Patients with Aorto-Iliac Aneurysm with implantation of a Iliac Branch device (IBE) and Viabahn Balloon Expandable ( VBx)
Interventions
Compare between patients where Gore Excluder Iliac Branch Endoprosthesis and the Hipogastric component can be used with the group where the Hipogastric component can't be used for anatomical issues and a Gore Viabahn VBX is used instead of the Hipogastric component
Eligibility Criteria
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 treated in the participants Hospitals.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Clinical Hospital
Santiago de Compostela, A Coruña, 15702, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jorge Fernández Noya, M.D
University Clinical Hospital- Santiago de Compostela
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2020
First Posted
April 22, 2020
Study Start
October 1, 2019
Primary Completion
December 31, 2020
Study Completion
December 31, 2021
Last Updated
April 22, 2020
Record last verified: 2020-04