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New Radiation-Free catheter could make aortic surgery safer

NCT ID NCT06549348

Symptom relief Sponsor: Philips Clinical & Medical Affairs Global Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new guidance system called LumiGuide that uses light instead of X-rays during a complex aortic aneurysm repair procedure (FEVAR). The goal is to see if it reduces the time patients and doctors are exposed to radiation. About 182 adults needing this surgery will be randomly assigned to either LumiGuide or standard X-ray guidance. The main measure is how long X-rays are used during the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LumiGuide (fiber-optic guided catheter system)
What this could lead to
If successful, this could make aortic aneurysm repair safer by reducing radiation exposure for patients and medical staff.
What could go wrong
This is an early-stage study with only 182 participants, so results may not apply to all patients. The new system might not work as well as traditional X-ray guidance in complex cases.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 182 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

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: * Subject will be undergoing a primary Fenestrated Endovascular Aortic Repair (FEVAR) procedure (including subjects with prior infrarenal EVAR or open repair) that includes the incorporation of visceral arteries into the repair. * Subject is able to give informed consent and is 18 years of age or older, or of legal age to give informed consent per state or national law. * Subject has a life expectancy of at least 2 years * Target vessels to be included are the Celiac Trunk, Superior Mesenteric Artery and Renal Arteries Exclusion Criteria: * Subjects undergoing an endovascular procedure that include branches or iliac branched devices (IBD) in the repair * Subject treated for re-intervention / staged procedure post-primary FEVAR procedure * Subjects intended to be treated for more than 4 target vessels (not counting the contralateral gate) * Subject treated for an emergent (\<24hrs after emergence) procedure * Subject with connective tissue disorder eg, Marfan's or Ehlers Danlos Syndrome * Subject with contrast allergies * Subject participates in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials may be allowed provided that pre-approval is obtained from Philips. * All vulnerable subjects such as immuno-compromised subjects, subjects lacking the capacity to provide consent, patients in emergency situations, pregnant or breast-feeding women, or any other subject who meets an exclusion criteria, according to applicable national laws, if any. * Subject unwilling or unable to comply with the protocol unable to understand verbal and/or written informed consent

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Conditions

The condition(s) this trial relates to.

aortic aneurysm

As listed by the trial registrant

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

Aortic aneurysm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Guys & St Thomas

    RECRUITING

    London, United Kingdom

  • Hôpital Universitaire Pitié-Salpêtrière

    RECRUITING

    Paris, France

  • Rigshospitalet University Hospital

    NOT_YET_RECRUITING

    Copenhagen, Denmark

  • UMC Maastricht

    RECRUITING

    Maastricht, Netherlands

  • UZ Gent

    RECRUITING

    Ghent, Belgium

  • University Medical Center Utrecht

    NOT_YET_RECRUITING

    Utrecht, 3508GA, Netherlands

  • University of Alabama

    RECRUITING

    Birmingham, Alabama, 35249, United States

  • University of Massachusetts

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

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