Gathering real-world data on LumiGuide: understanding its clinical use and benefits through the Xperience registry

Plain English summary of protocol

Background and study aims
When one or more blood vessels are dilated or blood flow is impaired they may require surgical repair. Nowadays most of these surgeries are done via the blood vessels, called “endovascular surgery”. During such surgery often a stent is placed within the weakened vessel wall. To get the stent in the correct position, a thin wire (guidewire) and a thin tube (catheter) are used. Typically, X‐ray radiation and contrast fluid are used to view navigation of the guidewire and catheter within the human body. Using X‐ray and contrast fluid can be harmful to the human body. A new kind of guidewire enabled with Fiber Optic RealShape (FORS) technology, called LumiGuide will be used during surgery in this registry. Inside this guidewire is a thin glass fiber. This allows the doctor to continuously see where the guidewire and catheter are inside the body in full shape (in color) and 3D, without needing X‐ray or contrast fluid. The rationale for conducting the LumiGuide Xperience Registry is to continue building ‘real-world’ evidence on how this recently introduced innovative technology is used in clinical practice, and on the potential benefits of using LumiGuide. The expected main benefits of using LumiGuide compared to using X-ray guidance include a reduction in radiation exposure to the subject, the operator, and supporting staff as well as procedure time reduction due to improved visualization during navigation. The fact that there is a high variety in types of endovascular procedures and high variation in radiation exposure (minutes to hours of fluoroscopy time) and procedure time (tens of minutes to many hours), a large data set is required to gain sufficient information per procedure type where LumiGuide is used. This data serves as input for hypothesis generation and study designs for future studies.

Who can participate?
Adult patients aged 18 years old and over who are indicated for endovascular repair procedures in the peripheral, aortic and aortic side branch vasculature

What does the study involve?
All subjects in the registry will undergo endovascular procedures as per the standard of care. During the endovascular procedure, LumiGuide will be used in every subject enrolled for navigation to the target vessels in the endovascular repair procedure. There are no study-related procedures for this study other than collecting patient and procedure-related data on top of normal clinical practice. There are no additional devices or medications required for the study other than the standard of care for treatment using FORS.

What are the possible benefits and risks of participating?
Participants may not experience any medical benefits. Use of LumiGuide may lead to a reduction of radiation exposure to the subject (and to the operator). Participation in the registry will provide no additional risk other than risks that are part of the endovascular repair.

Where is the study run from?
The registry will be performed by approximately 25 hospitals across Europe and USA

When is the study starting and how long is it expected to run for?
January 2024 until December 2026

Who is funding the study?
Philips Medical Systems Nederland BV

Who is the main contact?
Bart Wessels, Clinical Scientist, FORS venture
bart.wessels@philips.com

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• Austria
• Belgium
• Denmark
• England
• France
• Germany
• Netherlands
• Sweden
• United Kingdom
• United States of America

Study participating centres

Sponsor information

Funders

Funder type

Industry

Results and Publications

Editorial Notes

04/09/2024: Study's existence confirmed by Health Research Authority (HRA) (UK).