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

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.

• Iliac Branched Endoprosthesis (Procedure): Iliac Branched Endoprosthesis to treat iliac aneurysm

Primary outcomes

• primary patency [12 months]: The primary endpoint is primary patency of the iliac branched endoprosthesis at 12 months follow-up.

Secondary outcomes

• Secondary patency [12 months]: Secondary outcome is secondary patency at 12 months follow-up
• primary patency [24 months]: Secondary outcome is primary patency at 24 months follow-up
• secondary patency [24 months]: Secondary outcome is secondary patency at 24 months follow-up
• primary patency [60 months]: Secondary outcome is primary patency at 60 months follow-up
• secondary patency [60 months]: Secondary outcome is secondary patency at 60 months follow-up

Other outcomes

• Freedom from reintervention [60 months]: Freedom from reinterventions throughout latest follow-up
• Freedom from aneurysm rupture [60 months]: Freedom from rupture
• abdominal aortic aneurysm mortality [60 months]: AAA-related mortality
• freedom from all-cause mortality [60 months]: Freedom from all-cause mortality
• Aneurysm sac dynamics [60 months]: Aneurysm sac dynamics through follow-up of the aortic and iliac component
• Freedom from endoleaks [60 months]: Freedom from endoleaks

Sex: All

Inclusion Criteria:

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.

• MMPJ Reijnen, MD. PhD. Prof., Principal investigator, Rijnstate