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

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Aneurysm; Iliac Aneurysm
• Intervention / Treatment: Device: GORE® EXCLUDER® Iliac Branch Endoprosthesis

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 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

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Spain
  • A Coruña
    • Santiago De Compostela, A Coruña, Spain, 15702
      • Recruiting
      • University Clinical Hospital
      • Contact: Jorge FErnández Noya, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GORE® EXCLUDER® Iliac Branch Endoprosthesis & HGB; Patients with Aorto-Iliac Aneurysm with implantation of a Iliac Branch device (IBE) and the Hipogastric component (HGB)	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; Other Names: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesi
GORE® EXCLUDER® Iliac Branch Endoprosthesis & VBx; Patients with Aorto-Iliac Aneurysm with implantation of a Iliac Branch device (IBE) and Viabahn Balloon Expandable ( VBx)	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; Other Names: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of major adverse effects	Absence of morbidity and / or mortality related to the aneurysm or the device. Absence of mortality from any cause.	6 months
Assessment of quality of life	Based on the EuroQol 5D questionnaire	6 months

Collaborators and Investigators

• Sponsor: Asociacion para el Estudio de la Enfermedades Vasculares de Galicia
• Collaborators: W.L.Gore & Associates
• Investigators: Principal Investigator: Jorge Fernández Noya, M.D, University Clinical Hospital- Santiago de Compostela

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: April 19, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 19, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Iliac branch device; Aoto-iliac aneurysm; Hipogastric artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Iliac Aneurysm
• Other Study ID Numbers: AEEVGalicia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes