Actively Recruiting
Radiation Free Study
Led by Philips Clinical & Medical Affairs Global · Updated on 2025-09-05
182
Participants Needed
9
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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)
CONDITIONS
Official Title
Radiation Free Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject will be undergoing a primary Fenestrated Endovascular Aortic Repair (FEVAR) procedure including visceral artery incorporation
- Subject is 18 years of age or older or legally able to give informed consent
- 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
You will not qualify if you...
- Subjects undergoing an endovascular procedure including branches or iliac branched devices
- Subject treated for re-intervention or staged procedure post-primary FEVAR
- Subjects intended to be treated for more than 4 target vessels (excluding contralateral gate)
- Subject treated for an emergent procedure within 24 hours after emergence
- Subject with connective tissue disorders such as Marfan's or Ehlers Danlos Syndrome
- Subject with contrast allergies
- Subject participating in confounding drug or device trials without Philips pre-approval
- Vulnerable subjects including immuno-compromised, lacking consent capacity, emergency patients, pregnant or breastfeeding women
- Subject unwilling or unable to comply with protocol or provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
University of Alabama
Birmingham, Alabama, United States, 35249
Not Yet Recruiting
2
University of Massachusetts
Worcester, Massachusetts, United States, 01655
Actively Recruiting
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
4
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
5
UZ Gent
Ghent, Belgium
Not Yet Recruiting
6
Rigshospitalet University Hospital
Copenhagen, Denmark
Not Yet Recruiting
7
Hôpital Universitaire Pitié-Salpêtrière
Paris, France
Not Yet Recruiting
8
UMC Maastricht
Maastricht, Netherlands
Not Yet Recruiting
9
Guys & St Thomas
London, United Kingdom
Not Yet Recruiting
Research Team
B
Bart Wessels
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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