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

ConditionAneurysm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorRijnstate Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Patients Treated with the GORE® Iliac Branched Endoprosthesis

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • Iliac Branched Endoprosthesis

    Procedure/Surgery

    Iliac Branched Endoprosthesis to treat iliac aneurysm

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

primary patency

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

Time frame
12 months

Secondary outcomes

1

Secondary patency

Secondary outcome is secondary patency at 12 months follow-up

Time frame
12 months
2

primary patency

Secondary outcome is primary patency at 24 months follow-up

Time frame
24 months
3

secondary patency

Secondary outcome is secondary patency at 24 months follow-up

Time frame
24 months
4

primary patency

Secondary outcome is primary patency at 60 months follow-up

Time frame
60 months

Other outcomes

1

Freedom from reintervention

Freedom from reinterventions throughout latest follow-up

Time frame
60 months
2

Freedom from aneurysm rupture

Freedom from rupture

Time frame
60 months
3

abdominal aortic aneurysm mortality

AAA-related mortality

Time frame
60 months
4

freedom from all-cause mortality

Freedom from all-cause mortality

Time frame
60 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rijnstate Hospital

Lead sponsor

W.L. Gore & Associates, B.V.

Collaborator