Recruiting

LumiGuideRadiation Free Study

Sponsor:

Philips Clinical & Medical Affairs Global

Code:

NCT06549348

Conditions

Aortic Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance

Study Details

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)

Conditions

Aortic Aneurysm

Study ID

NCT06549348

Start date

Jul 3, 2025

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

182 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Task navigation using fluoroscopy guidance

Standard of care treatment using

active comparator: Task navigation using LumiGuide

Standard of care treatment using LumiGuide fluoroscopy guidance

Interventions

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

Primary outcome measure

To demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR). [ Time Frame: Fenestrated Endovascular Aortic Repair (FEVAR) procedure (skin to skin procedure time) ]

Central Contacts and Locations

Central contacts

Bart Wessels

bart.wessels@philips.com bart.wessels@philips.com

Locations

University of Alabama

Recruiting

Birmingham, Alabama, United States, 35249

Principal Investigator:

Adam Beck

University of Massachusetts

Recruiting

Worcester, Massachusetts, United States, 01655

Principal Investigator:

Andres Schanzer

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Darren Schneider

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Principal Investigator:

Mirza Baig

More Information

Sponsor

Philips Clinical & Medical Affairs Global

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Philips Clinical & Medical Affairs Global on 2026-06-15.