Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance
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
Study 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
Sex
ALL
Min age
18 Years
Max age
—
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 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
* Subject with connective tissue disorder eg, Marfan's or Ehlers Danlos Syndrome
* Subject with contrast allergies
* 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.
* 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
Primary outcome measure(s)
To demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR). — Fenestrated Endovascular Aortic Repair (FEVAR) procedure (skin to skin procedure time) Procedure fluoroscopy time
Trial sites (11)
Facility
City
Region
Status
University of Alabama
Birmingham
Alabama
Recruiting
Beth Israel Deaconess Medical Center
Boston
Massachusetts
Not Yet Recruiting
University of Massachusetts
Worcester
Massachusetts
Recruiting
University of Pennsylvania
Philadelphia
Pennsylvania
Recruiting
University of Texas Southwestern Medical Center
Dallas
Texas
Recruiting
UZ Gent
Ghent
Belgium
Recruiting
Rigshospitalet University Hospital
Copenhagen
Denmark
Not Yet Recruiting
Hôpital Universitaire Pitié-Salpêtrière
Paris
France
Recruiting
UMC Maastricht
Maastricht
Netherlands
Recruiting
University Medical Center Utrecht
Utrecht
Netherlands
Not Yet Recruiting
Guys & St Thomas
London
United Kingdom
Recruiting
More Philips Clinical & Medical Affairs Global trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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