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Radiation Free Study for Aortic Aneurysm

This study is for people with an aortic aneurysm who need a Fenestrated Endovascular Aortic Repair (FEVAR) procedure. Researchers are comparing a new guidance system called LumiGuide with the standard method (conventional fluoroscopy guidance) during FEVAR. The main goal is to see if LumiGuide can reduce the amount of radiation exposure during the procedure. You may be able to join if you are 18 or older and are having a primary FEVAR procedure that involves certain arteries. The study is currently recruiting 182 participants.

Study design
This is a randomized, unblinded study across multiple centers in the EU and US. It aims to enroll 182 participants.
What's involved
You would undergo a Fenestrated Endovascular Aortic Repair (FEVAR) procedure using either LumiGuide or conventional fluoroscopy guidance.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured during the Fenestrated Endovascular Aortic Repair (FEVAR) procedure (skin to skin procedure time).

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NCT06549348

Radiation Free Study

Recruiting
NAAges 18+InterventionalTreatment
Philips Clinical & Medical Affairs Global
~182 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance

At a glance

Recruiting sites
8 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR).
Measured over Fenestrated Endovascular Aortic Repair (FEVAR) procedure (skin to skin procedure time)

Conditions

Aortic Aneurysm

Explore related trials

Aortic Aneurysm

Where it's being run

11 sites across 9 states
Massachusetts2
Netherlands2
Alabama1
Pennsylvania1
Texas1
Belgium1
Denmark1
France1

Who to contact

Bart Wessels
[email protected]
[email protected]
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
Subject unwilling or unable to comply with the protocol unable to understand verbal and/or written informed consent

What this trial measures

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

    Procedure fluoroscopy time