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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)

NCT04356313 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-04-22

No results posted yet for this study

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.

Conditions

  • Aortic Aneurysm
  • Iliac Aneurysm

Interventions

DEVICE

GORE® EXCLUDER® Iliac Branch Endoprosthesis

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

Sponsors & Collaborators

  • W.L.Gore & Associates

    collaborator INDUSTRY

  • Asociacion para el Estudio de la Enfermedades Vasculares de Galicia

    lead OTHER

Principal Investigators

  • Jorge Fernández Noya, M.D · University Clinical Hospital- Santiago de Compostela

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2020-12-31
Completion
2021-12-31
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04356313 on ClinicalTrials.gov