Individual Patient Data Meta-Analysis of Prospective Studies of Patients Treated With the GORE® Iliac Branched Endoprosthesis

Aneurysm

iliac aneurysm, Iliac Branched Endoprosthesis, individual patient data analysis, meta analysis

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.

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Netherlands