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Radiation Free Study

Philips Clinical & Medical Affairs Global · NCT06549348

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
182
US sites recruiting
4
Study start
July 3, 2025
Record last updated
June 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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)

Being studied: Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance

Conditions: Aortic Aneurysm

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of Alabama

    Birmingham, AL 35249

    Site contact: Adam Beck

  • University of Massachusetts

    Worcester, MA 01655

    Site contact: Andres Schanzer

  • University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Darren Schneider

  • University of Texas Southwestern Medical Center

    Dallas, TX 75390

    Site contact: Mirza Baig

Study contacts (from the official record)

  • Bart Wessels · bart.wessels@philips.com · bart.wessels@philips.com
Radiation Free Study (NCT06549348) | Bored Studies