NCT06549348

Brief 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)

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Jul 2025

Geographic Reach
6 countries

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jul 2025Jun 2026

First Submitted

Initial submission to the registry

August 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

July 3, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

12 months

First QC Date

August 8, 2024

Last Update Submit

August 29, 2025

Conditions

Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

  • To demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR).

    Procedure fluoroscopy time

    Fenestrated Endovascular Aortic Repair (FEVAR) procedure (skin to skin procedure time)

Study Arms (2)

Task navigation using fluoroscopy guidance

NO INTERVENTION

Standard of care treatment using

Task navigation using LumiGuide

ACTIVE COMPARATOR

Standard of care treatment using LumiGuide fluoroscopy guidance

Radiation: Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance

Interventions

Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidanceRADIATION

Fenestrated Endovascular Aortic Repair (FEVAR) procedure done with either LumiGuide or conventional fluoroscopy guidance

Task navigation using LumiGuide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Subject unwilling or unable to comply with the protocol unable to understand verbal and/or written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of Alabama

Birmingham, Alabama, 35249, United States

NOT YET RECRUITING

University of Massachusetts

Worcester, Massachusetts, 01655, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

UZ Gent

Ghent, Belgium

NOT YET RECRUITING

Rigshospitalet University Hospital

Copenhagen, Denmark

NOT YET RECRUITING

Hôpital Universitaire Pitié-Salpêtrière

Paris, France

NOT YET RECRUITING

UMC Maastricht

Maastricht, Netherlands

NOT YET RECRUITING

Guys & St Thomas

London, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Central Study Contacts

Bart Wessels

CONTACT

bart.wessels@philips.combart.wessels@philips.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 12, 2024

Study Start

July 3, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)DK(1)BE(1)FR(1)US(4)NL(1)