Radiation Free Study (RadFree)

June 11, 2026 updated by: Philips Clinical & Medical Affairs Global

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Ghent, Belgium
        • Recruiting
        • UZ Gent
        • Principal Investigator:
          • Nathalie Moreels
  • Denmark
      • Copenhagen, Denmark
        • Not yet recruiting
        • Rigshospitalet University Hospital
        • Principal Investigator:
          • Timothy Resch
  • France
      • Paris, France
        • Recruiting
        • Hôpital Universitaire Pitié-Salpêtrière
        • Principal Investigator:
          • Laurent Chiche
  • Netherlands
      • Maastricht, Netherlands
        • Recruiting
        • UMC Maastricht
        • Principal Investigator:
          • Geert-Willem Schurink
      • Utrecht, Netherlands, 3508GA
        • Not yet recruiting
        • University Medical Center Utrecht
        • Principal Investigator:
          • Joost van Herwaarden
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Guys & St Thomas
        • Principal Investigator:
          • Bijan Modarai
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Recruiting
        • University of Alabama
        • Principal Investigator:
          • Adam Beck
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Marc Schermerhorn
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts
        • Principal Investigator:
          • Andres Schanzer
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Principal Investigator:
          • Darren Schneider
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Principal Investigator:
          • Mirza Baig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Task navigation using fluoroscopy guidance
Standard of care treatment using
Active Comparator: Task navigation using LumiGuide
Standard of care treatment using LumiGuide fluoroscopy guidance
Radiation: Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance
Fenestrated Endovascular Aortic Repair (FEVAR) procedure done with either LumiGuide or conventional fluoroscopy guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR).
Time Frame: Fenestrated Endovascular Aortic Repair (FEVAR) procedure (skin to skin procedure time)
Procedure fluoroscopy time
Fenestrated Endovascular Aortic Repair (FEVAR) procedure (skin to skin procedure time)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Clinical & Medical Affairs Global

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGT-00915-RadFree

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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