Radiation Free Study

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama
NOT_YET_RECRUITING
Birmingham
Massachusetts
University of Massachusetts
RECRUITING
Worcester
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Other Locations
Belgium
UZ Gent
NOT_YET_RECRUITING
Ghent
Denmark
Rigshospitalet University Hospital
NOT_YET_RECRUITING
Copenhagen
France
Hôpital Universitaire Pitié-Salpêtrière
NOT_YET_RECRUITING
Paris
Netherlands
UMC Maastricht
NOT_YET_RECRUITING
Maastricht
United Kingdom
Guys & St Thomas
NOT_YET_RECRUITING
London
Contact Information
Primary
Bart Wessels
bart.wessels@philips.com
bart.wessels@philips.com
Time Frame
Start Date: 2025-07-03
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 182
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Philips Clinical & Medical Affairs Global

This content was sourced from clinicaltrials.gov