Aortic AneurysmIBERVIXNCT04356313
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)
An observational study of Aortic Aneurysm and Iliac Aneurysm, run by Asociacion para el Estudio de la Enfermedades Vasculares de Galicia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Iliac Aneurysm
- What is being tested?
- GORE® EXCLUDER® Iliac Branch Endoprosthesis
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University Clinical Hospital
Santiago de Compostela, A Coruña, 15702
Jorge FErnández Noya, M.D
About this study
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.
Read more
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.
Read the 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
- 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
- Conditions
- Aortic Aneurysm, Iliac Aneurysm
- Being tested
- GORE® EXCLUDER® Iliac Branch Endoprosthesis
- Keywords
- Iliac branch device, Aoto-iliac aneurysm, Hipogastric artery
- Medical subject headings
- Aortic Aneurysm, Iliac Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® EXCLUDER® Iliac Branch EndoprosthesisDevice
Also called GORE® VIABAHN® VBX Balloon Expandable Endoprosthesi
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
| Study group | Role | What they receive |
|---|---|---|
| GORE® EXCLUDER® Iliac Branch Endoprosthesis & HGB | Patients with Aorto-Iliac Aneurysm with implantation of a Iliac Branch device (IBE) and the Hipogastric component (HGB) Receives: Device: GORE® EXCLUDER® Iliac Branch Endoprosthesis | |
| GORE® EXCLUDER® Iliac Branch Endoprosthesis & VBx | Patients with Aorto-Iliac Aneurysm with implantation of a Iliac Branch device (IBE) and Viabahn Balloon Expandable ( VBx) Receives: Device: GORE® EXCLUDER® Iliac Branch Endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 1 year
Safety and efficacy
IBE together with VBX compared to IBE all-in-one system
Measured: 6 months
Secondary outcomes (2)
Absence of major adverse effects
Absence of morbidity and / or mortality related to the aneurysm or the device. Absence of mortality from any cause.
Measured: 6 months
Assessment of quality of life
Based on the EuroQol 5D questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 Oct 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asociacion para el Estudio de la Enfermedades Vasculares de Galicia
- Sponsor type
- University, hospital or other
- Collaborators
- W.L.Gore & Associates
- Responsible party
- Sponsor
- Investigators
- Jorge Fernández Noya, M.D, Principal investigator, University Clinical Hospital- Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356313
- Sponsor's protocol ID
- AEEVGalicia
- Acronym
- IBERVIX
- Status last verified
- Apr 2020
- First submitted
- 19 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04356313
- Acronym / sponsor ID
- IBERVIX / AEEVGalicia
- Conditions
- Aortic Aneurysm, Iliac Aneurysm
- Keywords
- Iliac branch device, Aoto-iliac aneurysm, Hipogastric artery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asociacion para el Estudio de la Enfermedades Vasculares de GaliciaUniversity, hospital or other
- Collaborators
- W.L.Gore & Associates
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GORE® EXCLUDER® Iliac Branch Endoprosthesis & HGB | – | Device: GORE® EXCLUDER® Iliac Branch EndoprosthesisPatients with Aorto-Iliac Aneurysm with implantation of a Iliac Branch device (IBE) and the Hipogastric component (HGB) |
| GORE® EXCLUDER® Iliac Branch Endoprosthesis & VBx | – | Device: GORE® EXCLUDER® Iliac Branch EndoprosthesisPatients with Aorto-Iliac Aneurysm with implantation of a Iliac Branch device (IBE) and Viabahn Balloon Expandable ( VBx) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GORE® EXCLUDER® Iliac Branch EndoprosthesisAlso: GORE® VIABAHN® VBX Balloon Expandable EndoprosthesiCompare 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 | Device | GORE® EXCLUDER® Iliac Branch Endoprosthesis & HGB, GORE® EXCLUDER® Iliac Branch Endoprosthesis & VBx |
Primary outcome
General safety and efficacy at 6 months post-implant
Time frame: 6 months
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
Technical success
Time frame: 1 year
GORE® Excluder® IBE implant in the planned location. No conversion, death, type I or III endoleaks or obstruction of the extremity of the graft.
Safety and efficacy
Time frame: 6 months
IBE together with VBX compared to IBE all-in-one system
2 secondary outcomes
Absence of major adverse effects
Time frame: 6 months
Assessment of quality of life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Fernández Noya, M.D principal investigator
University Clinical Hospital- Santiago de Compostela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm and Iliac Aneurysm, run by Asociacion para el Estudio de la Enfermedades Vasculares de Galicia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Fernández Noya, M.D (+34629550241, jfernoy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General safety and efficacy at 6 months post-implant (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.