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

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.

Study Overview

• Status: Recruiting
• Conditions: Aneurysm
• Intervention / Treatment: Procedure: Iliac Branched Endoprosthesis

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 Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Suzanne Holewijn, PhD; Phone Number: 0031 88 0057282; Email: vascularsurgery@rijnstate.nl

Study Locations

• Netherlands
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6515 AD
      • Recruiting
      • Rijnstate
      • Contact: Suzanne Holewijn, PhD; Phone Number: 0031 88 0057282; Email: vascularsurgery@rijnstate.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients Treated with the GORE® Iliac Branched Endoprosthesis

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary patency	The primary endpoint is primary patency of the iliac branched endoprosthesis at 12 months follow-up.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary patency	Secondary outcome is secondary patency at 12 months follow-up	12 months
primary patency	Secondary outcome is primary patency at 24 months follow-up	24 months
secondary patency	Secondary outcome is secondary patency at 24 months follow-up	24 months
primary patency	Secondary outcome is primary patency at 60 months follow-up	60 months
secondary patency	Secondary outcome is secondary patency at 60 months follow-up	60 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from reintervention	Freedom from reinterventions throughout latest follow-up	60 months
Freedom from aneurysm rupture	Freedom from rupture	60 months
abdominal aortic aneurysm mortality	AAA-related mortality	60 months
freedom from all-cause mortality	Freedom from all-cause mortality	60 months
Aneurysm sac dynamics	Aneurysm sac dynamics through follow-up of the aortic and iliac component	60 months
Freedom from endoleaks	Freedom from endoleaks	60 months

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Collaborators: W.L. Gore & Associates, B.V.
• Investigators: Principal Investigator: MMPJ Reijnen, MD. PhD. Prof., Rijnstate

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: meta analysis; iliac aneurysm; Iliac Branched Endoprosthesis; individual patient data analysis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aneurysm; Iliac Aneurysm
• Other Study ID Numbers: 2026-2860

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data can only be shared on request and after all data sharing contracts are in place according to the institutions policy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No