Radiation Free Study

Launched by PHILIPS CLINICAL & MEDICAL AFFAIRS GLOBAL · Aug 8, 2024

Keywords

ClinConnect Summary

The Radiation Free Study is a clinical trial that aims to compare two different methods of guiding a specific medical procedure called Fenestrated Endovascular Aortic Repair (FEVAR), which is used to treat aortic aneurysms. The main goal of the study is to find out if using a new guidance system called LumiGuide results in less time spent using fluoroscopy (a type of real-time X-ray) compared to the traditional method. This study will take place at multiple sites in the US and Europe, and it is designed to gather information that can be applied to different healthcare settings.

To participate in this study, individuals must be at least 18 years old, have a life expectancy of at least two years, and be scheduled for a primary FEVAR procedure that involves specific blood vessels, like the Celiac Trunk and Renal Arteries. However, there are some people who won't be eligible, such as those with certain medical conditions or who are undergoing other types of procedures. If you join the study, you will receive the procedure with either the LumiGuide system or the traditional guidance method, and you will be monitored to see how well it works. This study is not yet recruiting participants, but it represents an important step in improving how these procedures are performed.

Gender

ALL

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