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Radiation Free Study

NCT06549348 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2025-09-05

No results posted yet for this study

Summary

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)

Conditions

  • Aortic Aneurysm

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

Sponsors & Collaborators

  • Philips Clinical & Medical Affairs Global

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-03
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • France
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06549348 on ClinicalTrials.gov