Radiation Free Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-03

Study Completion Date

2026-06-30

Brief Summary

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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)

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Detailed Description

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Conditions

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Aortic Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Task navigation using fluoroscopy guidance

Standard of care treatment using

Group Type NO_INTERVENTION

No interventions assigned to this group

Task navigation using LumiGuide

Standard of care treatment using LumiGuide fluoroscopy guidance

Group Type ACTIVE_COMPARATOR

Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance

Intervention Type RADIATION

Fenestrated Endovascular Aortic Repair (FEVAR) procedure done with either LumiGuide or conventional fluoroscopy guidance

Interventions

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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

Intervention Type RADIATION

Eligibility Criteria

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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.
* Subject unwilling or unable to comply with the protocol unable to understand verbal and/or written informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No