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NCT Number: NCT07704671

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

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.

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Key information

Conditions

Aneurysm Cardiovascular Diseases Iliac Aneurysm Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iliac Branched Endoprosthesis

Procedure

Iliac Branched Endoprosthesis to treat iliac aneurysm

Primary outcomes

  1. primary patency

    Time frame: 12 months

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

Secondary outcomes

  1. Secondary patency

    Time frame: 12 months

    Secondary outcome is secondary patency at 12 months follow-up

  2. primary patency

    Time frame: 24 months

    Secondary outcome is primary patency at 24 months follow-up

  3. secondary patency

    Time frame: 24 months

    Secondary outcome is secondary patency at 24 months follow-up

  4. primary patency

    Time frame: 60 months

    Secondary outcome is primary patency at 60 months follow-up

  5. secondary patency

    Time frame: 60 months

    Secondary outcome is secondary patency at 60 months follow-up

Other outcomes

  1. Freedom from reintervention

    Time frame: 60 months

    Freedom from reinterventions throughout latest follow-up

  2. Freedom from aneurysm rupture

    Time frame: 60 months

    Freedom from rupture

  3. abdominal aortic aneurysm mortality

    Time frame: 60 months

    AAA-related mortality

  4. freedom from all-cause mortality

    Time frame: 60 months

    Freedom from all-cause mortality

  5. Aneurysm sac dynamics

    Time frame: 60 months

    Aneurysm sac dynamics through follow-up of the aortic and iliac component

  6. Freedom from endoleaks

    Time frame: 60 months

    Freedom from endoleaks

Study contacts

Contact information is provided by the study sponsor or research team.

Suzanne Holewijn, PhD

CONTACT

[email protected]

0031 88 0057282

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Collaborators

  • W.L. Gore & Associates, B.V.

Registry information

Acronym: IPD-IBE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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