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New device shows promise for aneurysm repair in pelvic arteries

NCT ID NCT02345005

Disease control Sponsor: Rijnstate Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well a special stent (the Gore IBE device) works in real-world use for people with bulging blood vessels (aneurysms) in the belly or pelvis. Researchers tracked 100 patients who already had the device implanted to check if it stayed open and kept the aneurysm sealed. The goal was to see if the device is safe and effective over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

100 people

The number who actually took part.

Started

Nov 2014

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All patients in whom a Gore IBE was or will be implanted.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 years or older * Provided written informed consent for data release * Elective procedure; Indication for aorto-iliac endovascular stent graft repair, as determined by the treating physician Exclusion Criteria: * Patient is participating in another clinical study (RCT; interfering with endpoints) * Patient's life expectancy \<2 years as judged by the investigator * Patient has a psychiatric or other condition that may interfere with the study * Patient has a known allergy to any device component (ePTFE, FEP, nitinol) * Patients with a systemic infection who may be at increased risk of endovascular graft infection * Patient has a coagulopathy or uncontrolled bleeding disorder * Patient has a ruptured, leaking, or mycotic aneurysm * Patient had a CVA or an MI within the prior three months * Patient is pregnant (Female patients of childbearing potential only) * Other stents placed in CIA or hypogastric arteries than the Gore® EXCLUDER® iliac branch Endoprosthesis

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm Aneurysm vascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Abdominal aortic aneurysms Aneurysm Common iliac aneurysms

Contacts and locations

Locations

  • Auckland Hospital

    Auckland, New Zealand

  • Cardarelli Hospital

    Naples, Italy

  • Complexo Hospitelario Universitario de Ourense (CHUO)

    Ourense, Spain

  • Elisabeth Hospital

    Tilburg, Netherlands

  • Fondazione Poliambulanza

    Brescia, Italy

  • Hospital Casa de Salud

    Valencia, Spain

  • Rijnstate Hospital

    Arnhem, Gelderland, 6800 TA, Netherlands

  • San Filippo Neri Hospital

    Rome, Italy

More trials for these conditions

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