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RecruitingNCT06549348RadFreeUpdated Jun 15, 2026

Radiation Free Study

An interventional study of Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance in Aortic Aneurysm, sponsored by Philips Clinical & Medical Affairs Global. Recruiting at 11 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Philips Clinical & Medical Affairs Global (part of Philips) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
182
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

This is a prospective, randomized, unblinded, multi-center study. Sites were selected from different geographies (EU and US) with different clinical practice to ensure the results are more generalizable.

Primary objective is to demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR)

02

Conditions studied

  • Aortic Aneurysm

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03

In context

Aortic Aneurysm

222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.

This study's planned enrollment of 182 is above the median of 62 across 101 interventional studies indexed under Aortic Aneurysm.

Browse Aortic Aneurysm studies →

Lead sponsor

Philips Clinical & Medical Affairs Global is the lead sponsor of 85 studies on the registry; 25 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 12 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and is 18 years of age or older, or of legal age to give informed consent per state or national law.
  • Subject has a of at least 2 years
  • Target vessels to be included are the Celiac Trunk, Superior Mesenteric Artery and Renal Arteries

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
182 participants (estimated)

Study arms

  • No intervention
    Task navigation using fluoroscopy guidance

    Standard of care treatment using

  • Active comparator
    Task navigation using LumiGuide

    Standard of care treatment using LumiGuide fluoroscopy guidance

    Radiation: Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance

Interventions

  • RadiationMeasure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance

    Fenestrated Endovascular Aortic Repair (FEVAR) procedure done with either LumiGuide or conventional fluoroscopy guidance

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What researchers measure

Primary outcomes

  1. To demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR).

    Procedure fluoroscopy time

    Time frame: Fenestrated Endovascular Aortic Repair (FEVAR) procedure (skin to skin procedure time)

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Study locations

8 of 11 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06549348
Responsible party
Sponsor
First posted
Aug 12, 2024
Start date
Jul 3, 2025
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jun 15, 2026

Study contacts

Bart Wessels
Contact
bart.wessels@philips.com
bart.wessels@philips.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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