Radiation Free Study (RadFree)

Philips

Status

Begins enrollment this month

Conditions

Aortic Aneurysm

Treatments

Radiation: Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance

Study type

Interventional

Funder types

Industry

Identifiers

NCT06549348

IGT-00915-RadFree

Details and patient eligibility

About

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)

Enrollment

182 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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