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OpenTrials
Recruiting

NCT Number: NCT06549348

Radiation Free Study

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)

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Gent, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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).

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

    Procedure fluoroscopy time

Study contacts

Contact information is provided by the study sponsor or research team.

Bart Wessels

CONTACT

[email protected]

[email protected]

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Acronym: RadFree

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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