Clinical trial NCT06549348: Radiation Free Study
Official title: Radiation Free Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aortic Aneurysm
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: To demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR).
timeFrame: Fenestrated Endovascular Aortic Repair (FEVAR) procedure (skin to skin procedure time)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Gent
country: Belgium
facility: UZ Gent
city: Copenhagen
country: Denmark
facility: Rigshospitalet University Hospital
city: Paris
country: France
facility: Hôpital Universitaire Pitié-Salpêtrière
city: Maastricht
country: Netherlands
facility: UMC Maastricht
city: London
country: United Kingdom
facility: Guys & St Thomas
Study officials:
References: