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Recruiting NCT06549348

Radiation Free Study

No phase Interventional Aortic Aneurysm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance.
Who it may be relevant to
Registry conditions: Aortic Aneurysm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Belgium, Denmark, France, Netherlands +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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)

Interventions

  • 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

Primary outcome measures

  • 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)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • University of Alabama — Birmingham
  • Beth Israel Deaconess Medical Center — Boston
  • University of Massachusetts — Worcester
  • University of Pennsylvania — Philadelphia
  • University of Texas Southwestern Medical Center — Dallas
Netherlands · 2 centers
  • UMC Maastricht — Maastricht
  • University Medical Center Utrecht — Utrecht
Belgium · 1 center
  • UZ Gent — Ghent
Denmark · 1 center
  • Rigshospitalet University Hospital — Copenhagen
France · 1 center
  • Hôpital Universitaire Pitié-Salpêtrière — Paris
United Kingdom · 1 center
  • Guys & St Thomas — London

Identifiers

NCT: NCT06549348 · IGT-00915-RadFree

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗