← Back to all trials
Recruiting
NCT06549348
Radiation Free Study
Conditions: Aortic Aneurysm
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 182
Sponsor: Philips Clinical & Medical Affairs Global
Location: University of Alabama Birmingham Alabama
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 (\
Source: ClinicalTrials.gov (NCT06549348). StuddyBuddy aggregates publicly available trial information.