Radiation Free Study
Philips Clinical & Medical Affairs Global
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 endovas…
Interventions
- RadiationMeasure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance
Fenestrated Endovascular Aortic Repair (FEVAR) procedure done with either LumiGuide or conventional fluoroscopy guidance
Locations (9)
- University of AlabamaBirmingham, Alabama
- University of MassachusettsWorcester, Massachusetts
- University of PennsylvaniaPhiladelphia, Pennsylvania
- University of Texas Southwestern Medical CenterDallas, Texas
- UZ GentGhent
- Rigshospitalet University HospitalCopenhagen