An observational study in Aneurysm, sponsored by Rijnstate Hospital. Recruiting at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Rijnstate Hospital · Observational
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.
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.
381 studies on the registry are indexed under Aneurysm; 78 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 157 across 132 observational studies indexed under Aneurysm.
Browse Aneurysm studies →Rijnstate Hospital is the lead sponsor of 130 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients Treated with the GORE® Iliac Branched Endoprosthesis
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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.
Exclusion Criteria:
Only if authors decline participation and sharing the data.
Iliac Branched Endoprosthesis to treat iliac aneurysm
primary patency
The primary endpoint is primary patency of the iliac branched endoprosthesis at 12 months follow-up.
Time frame: 12 months
Secondary patency
Secondary outcome is secondary patency at 12 months follow-up
Time frame: 12 months
primary patency
Secondary outcome is primary patency at 24 months follow-up
Time frame: 24 months
secondary patency
Secondary outcome is secondary patency at 24 months follow-up
Time frame: 24 months
primary patency
Secondary outcome is primary patency at 60 months follow-up
Time frame: 60 months
secondary patency
Secondary outcome is secondary patency at 60 months follow-up
Time frame: 60 months
Freedom from reintervention
Freedom from reinterventions throughout latest follow-up
Time frame: 60 months
Freedom from aneurysm rupture
Freedom from rupture
Time frame: 60 months
abdominal aortic aneurysm mortality
AAA-related mortality
Time frame: 60 months
freedom from all-cause mortality
Freedom from all-cause mortality
Time frame: 60 months
Aneurysm sac dynamics
Aneurysm sac dynamics through follow-up of the aortic and iliac component
Time frame: 60 months
Freedom from endoleaks
Freedom from endoleaks
Time frame: 60 months
Plan to share: Undecided — Data can only be shared on request and after all data sharing contracts are in place according to the institutions policy.
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Dec 2027, 17 months later.
How these figures are worked out, and which studies are left out of them.
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