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NCT06549348NARecruiting

Radiation Free Study

Philips Clinical & Medical Affairs Global

Start Date

7/3/2025

Completion Date

6/30/2027

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

RADIATION

Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance

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Conditions

Aortic Aneurysm

Locations

University of Alabama

Birmingham, Alabama 35249

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

University of Massachusetts

Worcester, Massachusetts 01655

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

UZ Gent

Ghent,

Belgium

Rigshospitalet University Hospital

Copenhagen,

Denmark

Hôpital Universitaire Pitié-Salpêtrière

Paris,

France

UMC Maastricht

Maastricht,

Netherlands

University Medical Center Utrecht

Utrecht, 3508GA

Netherlands

Guys & St Thomas

London,

United Kingdom