NCT07704671

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

July 31, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

1.4 years

First QC Date

July 9, 2026

Last Update Submit

July 9, 2026

Conditions

Aneurysm

Keywords

iliac aneurysmIliac Branched Endoprosthesisindividual patient data analysismeta analysis

Outcome Measures

Primary Outcomes (1)

  • primary patency

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

    12 months

Secondary Outcomes (5)

  • Secondary patency

    12 months

  • primary patency

    24 months

  • secondary patency

    24 months

  • primary patency

    60 months

  • secondary patency

    60 months

Other Outcomes (6)

  • Freedom from reintervention

    60 months

  • Freedom from aneurysm rupture

    60 months

  • abdominal aortic aneurysm mortality

    60 months

  • +3 more other outcomes

Interventions

Iliac Branched EndoprosthesisPROCEDURE

Iliac Branched Endoprosthesis to treat iliac aneurysm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients Treated with the GORE® Iliac Branched Endoprosthesis

You may qualify if:

  • 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.

You may not qualify if:

  • Only if authors decline participation and sharing the data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate

Arnhem, Gelderland, 6515 AD, Netherlands

RECRUITING

MeSH Terms

Conditions

AneurysmIliac Aneurysm

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • MMPJ Reijnen, MD. PhD. Prof.

    Rijnstate

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne Holewijn, PhD

CONTACT

0031 88 0057282vascularsurgery@rijnstate.nl

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 15, 2026

Study Start

July 31, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

July 15, 2026

Record last verified: 2026-07

Locations

NL(1)