Radiation Free Study
Key facts
- Where
- Birmingham, Boston, Dallas, Philadelphia, and Worcester, United StatesSee the 5 sites
Where in United States
- University of AlabamaBirmingham, United StatesContact: Adam Beck (principal investigator)Taking people
- Beth Israel Deaconess Medical CenterBoston, United StatesContact: Marc Schermerhorn (principal investigator)Not yet recruiting
- University of Texas Southwestern Medical CenterDallas, United StatesContact: Mirza Baig (principal investigator)Taking people
- University of PennsylvaniaPhiladelphia, United StatesContact: Darren Schneider (principal investigator)Taking people
- University of MassachusettsWorcester, United StatesContact: Andres Schanzer (principal investigator)Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Philips Clinical & Medical Affairs Global
- Trial code
- NCT06549348
- Record updated
- 15 June 2026
- Original description
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
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)
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: 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.