AneurysmIPD-IBENCT07704671
Individual Patient Data Meta-Analysis of Prospective Studies of Patients Treated With the GORE® Iliac Branched Endoprosthesis
An observational study of Aneurysm, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Most studies investigating the outcomes of the iliac branched endoprosthesis (IBE) are of relatively small sample sizes. This individual patient data (IPD) analysis is a retrospective analysis of all available individual patient data on treatments of aorto-iliac with the Gore Iliac Branch Endoprosthesis device from… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aneurysm
- What is being tested?
- Iliac Branched Endoprosthesis
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 Jul 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients Treated with the GORE® Iliac Branched Endoprosthesis
Who may be able to join
- The IPD-IBE is a retrospective analysis of all available individual patient data on treatments of aorto-iliac with the Gore Iliac Branch Endoprosthesis device from previous peer reviewed publications. All authors that confirm to participate and share the data.
Who cannot join
- Only if authors decline participation and sharing the data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Rijnstate
Arnhem, Gelderland, 6515 AD
Suzanne Holewijn, PhD, 0031 88 0057282, vascularsurgery@rijnstate.nl
About this study
Most studies investigating the outcomes of the iliac branched endoprosthesis (IBE) are of relatively small sample sizes. This individual patient data (IPD) analysis is a retrospective analysis of all available individual patient data on treatments of aorto-iliac with the Gore Iliac Branch Endoprosthesis device from previous peer reviewed publications. Corresponding authors and/or sponsors of the trials will be contacted to share the databases if available and to coauthor the publication. Th purpose of the IPD is to gain more robust evidence on the technical and clinical outcomes of the Gore IBE device using the individual patient data from as much publications as possible and to provide a sample size to perform meaningful subgroup analysis on the various outcome parameters.
Read the detailed description
Corresponding authors and/or sponsors of the trials will be contacted to share the databases if available and to coauthor the publication.
Data transfer agreements will be arranged. After receipt of the databases, mapping will be done with the master database. Prior to merging the individual datasets, an IPD database will be created according to current reporting standards. During the conversion process, fields of each original study database will be mapped to the prebuilt database. Additionally, a conversion scheme in the log will be saved based on the value label defined for the original field and the IPD field. After initial mapping and conversion, the conversion log and data copying per study cohort will be checked. Any discrepancies in the meaning of column headings or definitions will be resolved by means of a discussion with the relevant author. A copy of the IPD database will be saved for each database conversion; all copies will thereafter be merged into one master database. Any empty fields in the prebuilt IPD database will be culled.
- Conditions
- Aneurysm
- Being tested
- Iliac Branched Endoprosthesis
- Keywords
- iliac aneurysm, Iliac Branched Endoprosthesis, individual patient data analysis, meta analysis
- Medical subject headings
- Aneurysm, Iliac Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iliac Branched EndoprosthesisProcedure or surgery
Iliac Branched Endoprosthesis to treat iliac aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
primary patency
The primary endpoint is primary patency of the iliac branched endoprosthesis at 12 months follow-up.
Measured: 12 months
Secondary outcomes (5)
Secondary patency
Secondary outcome is secondary patency at 12 months follow-up
Measured: 12 months
primary patency
Secondary outcome is primary patency at 24 months follow-up
Measured: 24 months
secondary patency
Secondary outcome is secondary patency at 24 months follow-up
Measured: 24 months
primary patency
Secondary outcome is primary patency at 60 months follow-up
Measured: 60 months
secondary patency
Secondary outcome is secondary patency at 60 months follow-up
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- W.L. Gore & Associates, B.V.
- Responsible party
- Principal investigator, Michel Reijnen, Rijnstate Hospital
- Investigators
- MMPJ Reijnen, MD. PhD. Prof., Principal investigator, Rijnstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704671
- Sponsor's protocol ID
- 2026-2860
- Acronym
- IPD-IBE
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data can only be shared on request and after all data sharing contracts are in place according to the institutions policy.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Patient Data Meta-Analysis of Prospective Studies of Patients Treated With the GORE® Iliac Branched Endoprosthesis
- ClinicalTrials.gov ID
- NCT07704671
- Acronym / sponsor ID
- IPD-IBE / 2026-2860
- Conditions
- Aneurysm
- Keywords
- iliac aneurysm, Iliac Branched Endoprosthesis, individual patient data analysis, meta analysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- W.L. Gore & Associates, B.V.
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Jul 2026 (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.
Most studies investigating the outcomes of the iliac branched endoprosthesis (IBE) are of relatively small sample sizes. This individual patient data (IPD) analysis is a retrospective analysis of all available individual patient data on treatments of aorto-iliac with the Gore Iliac Branch Endoprosthesis device from previous peer reviewed publications. Corresponding authors and/or sponsors of the trials will be contacted to share the databases if available and to coauthor the publication. Th purpose of the IPD is to gain more robust evidence on the technical and clinical outcomes of the Gore IBE device using the individual patient data from as much publications as possible and to provide a sample size to perform meaningful subgroup analysis on the various outcome parameters.
Detailed description
Corresponding authors and/or sponsors of the trials will be contacted to share the databases if available and to coauthor the publication.
Data transfer agreements will be arranged. After receipt of the databases, mapping will be done with the master database. Prior to merging the individual datasets, an IPD database will be created according to current reporting standards. During the conversion process, fields of each original study database will be mapped to the prebuilt database. Additionally, a conversion scheme in the log will be saved based on the value label defined for the original field and the IPD field. After initial mapping and conversion, the conversion log and data copying per study cohort will be checked. Any discrepancies in the meaning of column headings or definitions will be resolved by means of a discussion with the relevant author. A copy of the IPD database will be saved for each database conversion; all copies will thereafter be merged into one master database. Any empty fields in the prebuilt IPD database will be culled.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients Treated with the GORE® Iliac Branched Endoprosthesis
Key inclusion criteria (1 listed)
- The IPD-IBE is a retrospective analysis of all available individual patient data on treatments of aorto-iliac with the Gore Iliac Branch Endoprosthesis device from previous peer reviewed publications. All authors that confirm to participate and share the data.
Key exclusion criteria (1 listed)
- Only if authors decline participation and sharing the data.
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 |
|---|---|---|
| Iliac Branched EndoprosthesisIliac Branched Endoprosthesis to treat iliac aneurysm | Procedure or surgery | – |
Primary outcome
primary patency
Time frame: 12 months
The primary endpoint is primary patency of the iliac branched endoprosthesis at 12 months follow-up.
5 secondary outcomes
Secondary patency
Time frame: 12 months
primary patency
Time frame: 24 months
secondary patency
Time frame: 24 months
primary patency
Time frame: 60 months
secondary patency
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Undecided. Data can only be shared on request and after all data sharing contracts are in place according to the institutions policy.
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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.
MMPJ Reijnen, MD. PhD. Prof. principal investigator
Rijnstate
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 Aneurysm, run by Rijnstate Hospital at 1 site in Netherlands.
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 1 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: looking for participants now, as of the sponsor's last update on 15 Jul 2026. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzanne Holewijn, PhD (0031 88 0057282, vascularsurgery@rijnstate.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary patency (time frame: 12 months). 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 15 Jul 2026.