Radiation Free Study

Not Applicable

Not yet recruiting

• Conditions: Aortic Aneurysm
• Interventions: Radiation: Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance

• Registration Number: NCT06549348
• Lead Sponsor: Philips Clinical & Medical Affairs Global

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-08
• Study First Posted: 2024-08-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06
• Study Start: 2025-06-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Task navigation using LumiGuide	Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance	Standard of care treatment using LumiGuide fluoroscopy guidance

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (9)

UMC Maastricht; 🇳🇱 Maastricht, Netherlands

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; 🇧🇪 Gent, Belgium

Rigshospitalet University Hospital; 🇩🇰 Copenhagen, Denmark

Hôpital Universitaire Pitié-Salpêtrière; 🇫🇷 Paris, France

Guys & St Thomas; 🇬🇧 London, United Kingdom