Completed
Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis for the Treatment of Common Iliac Artery Aneurysms or Aorto-iliac Aneurysms
What is being tested
GORE® EXCLUDER® Iliac Branch Endoprosthesis
Device
Who is being recruted
Over 21 Years
+21 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: October 2013
Summary
Principal SponsorW.L.Gore & Associates
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2013
Actual date on which the first participant was enrolled.The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized, multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE Device in subjects with common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).
Official TitleEvaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis for the Treatment of Common Iliac Artery Aneurysms or Aorto-iliac Aneurysms
Principal SponsorW.L.Gore & Associates
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
64 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
8 inclusion criteria required to participate
Common iliac aneurysm with or without concomitant abdominal aortic aneurysm
Adequate native anatomy to receive the EXCLUDER® and Iliac Branch Endoprostheses
Male or infertile female
An Informed Consent Form signed by Subject or legally authorized representative
Show More Criteria
13 exclusion criteria prevent from participating
Mycotic or ruptured aneurysm
Known concomitant thoracic aortic aneurysm which requires intervention
American Society of Anesthesiologists (ASA) Physical Status classification system class V (moribund patient not expected to live 24 hours with or without operation)
Renal insufficiency defined or patient undergoing dialysis
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGORE® EXCLUDER® Iliac Branch Endoprosthesis
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center