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Radiation Free Study

Sponsor: Philips Clinical & Medical Affairs Global

NCT ID: NCT06549348

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance (radiation)
How long the study runs
Study runs about 23 months (dates as stated)
About the drug or intervention
Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance — radiation: Fenestrated Endovascular Aortic Repair (FEVAR) procedure done with either LumiGuide or conventional fluoroscopy guidance
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by Philips Clinical & Medical Affairs Global, is for people having a planned procedure called fenestrated endovascular aortic repair (FEVAR) to treat an aortic aneurysm. The study is called the Radiation Free Study. The aim appears to be linked to the procedure itself, but further details are not stated — ask the trial team.

Who can take part

  • You are due to have a first FEVAR procedure (this may include people who have had a previous aortic repair below the kidneys, either with a stent or by open surgery) that includes arteries supplying the organs in the repair.
  • You can give informed consent and are aged 18 or over, or are of legal age to consent where you live.
  • You are expected to live for at least 2 more years.
  • The arteries to be treated are the celiac trunk, the superior mesenteric artery, and the renal (kidney) arteries.

Who may not be able to

  • Your repair uses branched devices or iliac branched devices.
  • You are having a repeat or staged procedure after a first FEVAR.
  • You are being treated for more than 4 target vessels (not counting the contralateral gate).
  • You are being treated as an emergency (within 24 hours).
  • You have a connective tissue disorder, such as Marfan's or Ehlers Danlos syndrome.
  • You are allergic to contrast (the dye used in scans).
  • You are taking part in another drug or device trial that could affect this study, unless pre-approved by Philips.
  • You are in a vulnerable group, such as having a weakened immune system, lacking capacity to consent, being in an emergency situation, or being pregnant or breastfeeding.
  • You are unwilling or unable to follow the study plan or understand verbal or written consent.

What taking part involves

  • • Not stated — ask your trial team.
  • • You would be having a FEVAR procedure as part of your planned care.

Time commitment: Number of visits and study duration are not stated — ask the trial team; taking part involves having the FEVAR procedure and being treated under the study plan.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
182
Started
2025-07-03
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for aortic aneurysm
  • • NA - 182 participants
  • • This is a prospective, randomized, unblinded, multi-center study

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with aortic aneurysm

Where?

  • • London - Guys & St Thomas

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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)

Aortic Aneurysm

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Subject is able to give agreement to take part and is 18 years of age or older, or of legal age to give agreement to take part...
  • ✓Subject has a expected to live at least 2 $2
  • ✓Target vessels to be included are the Celiac Trunk, Superior Mesenteric Artery and kidney Arteries

Who cannot take part

  • ✗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
See the full criteria
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

Where Is This Study? (1 UK site)

Guys & St Thomas

London, United Kingdom

Recruiting
Site contact (verified)
Bijan ModaraiPrincipal Investigator

How to Get in Touch

Bart Wessels

Sponsor contact

CONTACT

bart.wessels@philips.com bart.wessels@philips.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06