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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Fenestrated Endovascular Aortic Repair (FEVAR) procedure done with either LumiGuide or conventional fluoroscopy guidance
University of Alabama
Birmingham, Alabama, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
NOT_YET_RECRUITINGTo 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)
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University of Massachusetts
Worcester, Massachusetts, United States
RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGUniversity of Texas Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGUZ Gent
Ghent, Belgium
RECRUITINGRigshospitalet University Hospital
Copenhagen, Denmark
NOT_YET_RECRUITINGHôpital Universitaire Pitié-Salpêtrière
Paris, France
RECRUITINGUMC Maastricht
Maastricht, Netherlands
RECRUITINGUniversity Medical Center Utrecht
Utrecht, Netherlands
NOT_YET_RECRUITING...and 1 more locations