Radiation Free Study
ConditionAortic Aneurysm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhilips Clinical & Medical Affairs Global
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance
RadiationFenestrated Endovascular Aortic Repair (FEVAR) procedure done with either LumiGuide or conventional fluoroscopy guidance
Treatment groups
182 Participants
are divided into 2 treatment groupsGroup A: Task navigation using fluoroscopy guidanceNo intervention 0 interventions
Group B: Task navigation using LumiGuideActive comparator 1 intervention
Trial outcomes
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)Sponsors and contacts
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Source ClinicalTrials.gov