Meta-Analysis of Patient Data for Aorto-Iliac Aneurysm Treatment Using the Gore Iliac Branched Endoprosthesis Device

What this Trial Is About

Researchers are conducting an individual patient data IPD meta-analysis to gather more comprehensive evidence on the outcomes of using the Gore Iliac Branch Endoprosthesis IBE device to treat aorto-iliac aneurysms. This study combines data from previous peer-reviewed publications to increase sample size and enable meaningful subgroup analyses of technical and clinical results. The analysis aims to better understand the devices performance by using individual patient-level data collected from multiple studies. The study involves collecting and harmonizing individual patient data from original study databases shared by corresponding authors and sponsors of previous trials. Data transfer agreements will be established, and each dataset will be mapped and converted to a master database following current reporting standards. Discrepancies in data definitions will be resolved through discussion with original authors before merging all datasets into a comprehensive IPD database. Participants are patients previously treated with the Gore IBE device, whose anonymized data are being combined for analysis. Researchers will evaluate outcomes such as primary and secondary patency at 12, 24, and 60 months post-treatment. This approach enables detailed assessment of the devices long-term performance. The study involves no new interventions or visits, as it is a retrospective observational data analysis scheduled to complete by the end of 2027.

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