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RECRUITING
NCT06549348
NA

Radiation Free Study

Sponsor: Philips Clinical & Medical Affairs Global

View on ClinicalTrials.gov

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

RADIATION

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