NCT06549348 · Philips Clinical & Medical Affairs Global
Radiation Free Study
(RadFree)
What this study is about
This is a forward-looking, randomly assigned, unblinded, multi-center study. Sites were selected from different geographies (EU and US) with different clinical practice to ensure the results are more generalizable.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Boston, Massachusetts
- Worcester, Massachusetts
- Philadelphia, Pennsylvania
- Dallas, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations