Status:
RECRUITING
Radiation Free Study
Lead Sponsor:
Philips Clinical & Medical Affairs Global
Conditions:
Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
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 generalizab...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT06549348
Start Date
July 3 2025
End Date
June 30 2026
Last Update
September 5 2025
Active Locations (9)
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1
University of Alabama
Birmingham, Alabama, United States, 35249
2
University of Massachusetts
Worcester, Massachusetts, United States, 01655
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390