Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac Revascularization

December 23, 2025 updated by: W.L.Gore & Associates
The IBE 25-05 study will be a prospective, non-randomized, multicenter, interventional two arm evaluation designed to assess the safety and effectiveness of the GORE® EXCLUDER® IBE Plus Stent Graft in patients with common iliac artery aneurysm (CIAA) or aorto-iliac aneurysm (AIAA) disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of this clinical trial is to evaluate the safety and effectiveness of the GORE® EXCLUDER® IBE Plus Stent Graft for endovascular revascularization in patients with common iliac artery aneurysm (CIAA) or aorto-iliac aneurysm (AIAA) disease requiring intervention. The study population includes adults aged 22 years and older, both male and infertile female, who meet specific anatomical criteria.

The main questions it aims to answer are:

Does the IBE Plus Stent Graft provide clinical benefit and maintain safety? Does the device maintain effectiveness?

Researchers will evaluate two parallel study arms:

  • Primary Arm: Subjects with AIAA/CIAA pathology, including a subset newly eligible for treatment with IBE Plus.
  • Secondary Arm: Subjects requiring EVAR revision for previously treated AIAA/CIAA.

Participants will:

  • Undergo pre-procedure assessments (informed consent, physical exam, lab tests, and CTA imaging).
  • Receive endovascular treatment with the IBE Plus Stent Graft.
  • Attend follow-up visits at 1, 6, 12, 24, 36, 48, and 60 months post-procedure for physical exams, lab tests, and imaging.
  • Be monitored for adverse events, device performance, and need for reintervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Primary Arm Inclusion Criteria

The subject is / has:

  1. The target lesion and surrounding vasculature are amenable to treatment with IBE Plus system requirements:

    1.1. Common iliac artery to be treated must have a common iliac diameter ≥ 25 mm with or without concomitant abdominal aortic aneurysm 1.2. Minimum diameter ≥ 12 mm within the proximal implantation zone of IBE Plus as assessed by flow lumen; calcium excluded 1.3. Intended treatment length must be ≥ 100 mm in unilateral application or a combination of ≥ 100 mm and ≥ 150 mm in bilateral application 1.4. The planned distal target landing zone within the internal iliac artery is within the trunk of the internal iliac artery with at least 15 mm of seal zone 1.5. Iliac vasculature meets anatomical specifications for selected VBX Stent Graft(s)

  2. Aortoiliac vasculature meets anatomical specifications for selected EXC or EXCC Devices
  3. Informed Consent Form (ICF) is signed by subject
  4. Subject is capable of complying with protocol requirements, including follow-up
  5. Life expectancy > 2 years
  6. Age ≥ 22 years at time of informed consent signature
  7. Male or infertile female

Secondary Arm Inclusion Criteria

The subject is / has:

  1. Present with any one of the following treatment indications:

    1.1. The subject has a confirmed Type Ib endoleak of a previously implanted Gore EVAR device where its distal portion within the common iliac artery has a luminal diameter of at least 12 mm. Minimum diameter of ≥ 12 mm within the proximal implantation zone of IBE Plus as assessed by flow lumen; calcium excluded 1.2. The subject has documented diameter growth of the common iliac artery of at least ≥ 5 mm in the presence of a previously implanted Gore EVAR device where its distal portion within the common iliac artery has a luminal diameter of at least 12 mm. The planned distal target landing zone within the internal iliac artery is within the trunk of the internal iliac artery with at least 15 mm of seal zone

  2. Aortoiliac vasculature meets anatomical specifications for selected EXC or EXCC Devices
  3. Informed Consent Form (ICF) is signed by subject
  4. Subject is capable of complying with protocol requirements, including follow-up
  5. Life expectancy > 2 years
  6. Age ≥ 22 years at time of informed consent signature
  7. Male or infertile female

Primary Arm and Secondary Arm Exclusion Criteria

The subject is / has:

  1. Mycotic or ruptured aneurysm
  2. ASA class V (moribund patient not expected to live 24 hours with or without operation)
  3. Renal insufficiency defined as creatinine > 1.8 mg/dL or undergoing dialysis
  4. NYHA class IV
  5. Dissected, heavily calcified, or heavily thrombosed landing zone(s)
  6. Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
  7. Participating in another investigational drug or medical device study within one year of study enrollment
  8. An active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication) that may place the patient at increased risk of endovascular infection. Subjects with a chronic infection (such as HIV, Hepatitis C, etc.) that is well controlled under their current treatment regimen may be eligible
  9. Degenerative connective tissue disease, e.g., Marfan's or Ehler-Danlos Syndrome
  10. Planned concomitant surgical procedure or major surgery within 30 days of treatment date
  11. History of drug abuse, e.g., cocaine or amphetamine, within 1 year of treatment
  12. Known sensitivities or allergies to the device materials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Primary Arm
Subjects representative of AIAA/ CIAA pathology to be treated with IBE Plus Stent Graft
Device: GORE® EXCLUDER® IBE Plus Stent Graft
Endovascular aneurysm repair with the GORE® EXCLUDER® IBE Plus Stent Graft
Experimental: Secondary Arm
Subjects representative of EVAR revision to be treated with IBE Plus Stent Graft
Device: GORE® EXCLUDER® IBE Plus Stent Graft
Endovascular aneurysm repair with the GORE® EXCLUDER® IBE Plus Stent Graft

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Freedom From Composite of the Following: All-Cause Mortality, Serious Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Function Decline, Conversion to Open Surgical Repair
Time Frame: Through 30 days post-treatment

Freedom from composite of any of the following events:

  • All-cause mortality
  • Serious stroke
  • Myocardial infarction
  • Bowel ischemia requiring surgical resection or not resolving with medical therapy
  • Paraplegia (grade 3)
  • Respiratory failure requiring prolonged (>24 hours from anticipated) mechanical ventilation or reintubation
  • Renal function decline resulting in >50% reduction in baseline eGFR or new-onset dialysis
  • Conversion to open surgical repair
Through 30 days post-treatment
Freedom From Composite of the Following: IBE Plus-Related Reinterventions Involving Type Ib / Ic or Type III Endoleak, Total Occlusion of Any IBE Plus Component, Loss of Primary Patency of the Internal Iliac Device Component
Time Frame: Through the 6 month follow-up visit

Composite of the following events:

  • IBE Plus-related reinterventions involving Type Ib / Ic or Type III endoleak
  • Total occlusion of any IBE Plus component
  • Loss of primary patency of the internal iliac device component
Through the 6 month follow-up visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Freedom From New Onset Buttock Claudication on an IBE Plus-Treated Side
Time Frame: Through the 6 month follow-up visit
Freedom from new onset buttock claudication on an IBE Plus-treated side
Through the 6 month follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
W.L.Gore & Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IBE 25-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aorto Iliac Aneurysm

Clinical Trials on GORE® EXCLUDER® IBE Plus Stent Graft

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings