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Radiation Free Study
Sponsor: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
182
Start Date
2025-07-03
Completion Date
2026-06-30
Last Updated
2025-09-05
Healthy Volunteers
No
Conditions
Interventions
Measure 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 Alabama
Birmingham, Alabama, United States
University of Massachusetts
Worcester, Massachusetts, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
UZ Gent
Ghent, Belgium
Rigshospitalet University Hospital
Copenhagen, Denmark
Hôpital Universitaire Pitié-Salpêtrière
Paris, France
UMC Maastricht
Maastricht, Netherlands
Guys & St Thomas
London, United Kingdom