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LumiGuide compared with standard X-ray guidance during aortic aneurysm repair

Tests whether LumiGuide shortens X-ray time during fenestrated aortic aneurysm repair.

Key facts

Who runs it
Philips Clinical & Medical Affairs Global
Where
London, United KingdomSee the siteAlso in 5 other countries, 10 sites
Trial code
Registry title
Radiation Free Study
Status
Recruiting
People taking part
182 people, planned
Started
3 Jul 2025
Expected to end
30 Jun 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance
Record updated
15 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with an aortic aneurysm (a bulge in the main body artery) who will have a first FEVAR repair. FEVAR is a repair done through the blood vessels with a stent graft that has openings for the gut and kidney arteries.

Age
18 years or older, or of legal age to give consent under local law.
Sex
All sexes can join.
Disease stage
Aortic aneurysm needing a first FEVAR repair that includes the arteries to the gut and kidneys (Celiac Trunk, Superior Mesenteric Artery and Renal Arteries). People must be expected to live at least 2 years.
Earlier treatment
People who had an earlier infrarenal EVAR or open repair can join. People having a repeat or staged procedure after a first FEVAR cannot join.

Main reasons for not taking part

  • Repair using branches or iliac branched devices (IBD), or more than 4 target vessels
  • Emergency procedure (less than 24hrs after the problem started)
  • Connective tissue disorder, such as Marfan's or Ehlers Danlos Syndrome
  • Allergy to contrast dye
  • Pregnant or breast-feeding, weak immune system, or unable to give consent

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Subject with connective tissue disorder eg, Marfan's or Ehlers Danlos Syndrome
  • Subject with contrast allergies
  • 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
  • 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

Where in United Kingdom

Also in 5 other countries, 10 sites

  • Guys & St ThomasLondon, United KingdomContact: Bijan Modarai (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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)

The 2 groups in the trial

  • Task navigation using fluoroscopy guidanceNo study treatment, for comparison

    Standard of care treatment using

  • Task navigation using LumiGuideExisting treatment, for comparison

    Standard of care treatment using LumiGuide fluoroscopy guidance

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Radiation Free Study
Plain-language title
LumiGuide compared with standard X-ray guidance during aortic aneurysm repairGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
15 June 2026