ReVEAL iFR - 180102
Research type
Research Study
Full title
Radiographic imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)
IRAS ID
256297
Contact name
Kare Tang
Contact email
Sponsor organisation
Philips IGT-D
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
Patients undergoing coronary angiography, after suffering from chest pain or shortness of breath, potentially due to a narrowing of one of the heart arteries, are potential candidates for participation in the ReVEAL iFR study.
Current best practice is to measure the pressure across narrowed arteries and thus to help determine the best treatment for affected patients (these measurements are called the Fractional Flow Reserve or FFR and instant Fractional Flow Reserve or iFR). This is done using a special wire, called a pressure wire, which is passed through the narrowing in the artery to measure the pressure. If the pressure is found to be reduced, then the artery is treated with stents. After the stent is placed the same pressure measurements will be performed again to see if the stenting has been successful.
The purpose of this study is to collect data to compare pressure wire measurements using the iFR and FFR technique, which is standard of care, against software that can calculate the iFR and FFR value based on the patients' x-ray results.
The results will be used to see if the software is accurate and reliable compared to the real measurements.
The Philips pressure wires used in this study all have regulatory clearance/approval in the United States, the European Union and the UK. There is no change to the standard interventional treatment that patients would normally receive. Patients will only get additional pressure measurements made which is different from standard of care. It may require more x-rays to get these additional pressure measures.
Participation of each patient in the research study will last until 48 hours after the procedure.REC name
North West - Preston Research Ethics Committee
REC reference
19/NW/0336
Date of REC Opinion
25 Jul 2019
REC opinion
Further Information Favourable Opinion