DEFINE GPS
Research type
Research Study
Full title
Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect: Guided Physiologic Stenting (DEFINE GPS)
IRAS ID
294972
Contact name
Becky Inderbitzen
Contact email
Sponsor organisation
PHILIPS IGT-D
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 7 months, 31 days
Research summary
The DEFINE GPS clinical study seeks to determine if a new type of image guidance for treating heart disease will help patients more than the current image guidance method. Patients with coronary heart disease suffer from chest pain and shortness of breath due to blockages in the heart vessels. Currently, to treat these blockages, a tube is placed into the patient’s heart vessel and a small wire cage called a “stent” is inserted to re-establish normal blood flow in the heart vessel. The standard method for guiding the placement of a stent is by injecting dye into the vessel and visualizing its flow profile in an x-ray. Sometimes, the blockage causing the patient’s symptoms is not accurately captured using only the x-ray. Failure to accurately visualize and then treat the location of the blockage is believed to be why some patients still suffer chest pain after treatment.
Philips has developed technology to better pinpoint the location of the blockages that should be treated, involving a pressure wire (a 0.33mm thin wire, with a pressure sensor on its end). This wire is placed in the heart vessel, and then slowly retracted, recording pressure at each spot in the vessel. The pressure recording is then overlayed on top of the x-ray image, displaying a number of dots where the biggest pressure changes occur – showing the precise location of the blockages. This technology may help to guide the placement of the stents and prevent patients from still suffering from chest pain following stent placement.
Philips is funding DEFINE GPS to compare use of the standard x-ray method to the new technology that adds the pressure information on top of the x-ray to guide the placement of stents. Patients with heart disease needing a stent placed for treatment will be asked to participate and randomly assigned (like a toss of a coin) to either type of guidance for their treatment. The information used to place their stent is the only difference in way the two groups of patients will be treated.
Patients that agree to be in the study will undergo follow-up phone calls with the research team 30-days, 6-months, 1-year, and 2-years following their initial treatment. Patients will provide information on their health status, medication status, and take 2 short questionnaires to collect quality-of-life information during each of these phone calls. Comparisons in clinical heart health and cost associated will be made over the 2 years of follow up between the 2 groups.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
21/SC/0234
Date of REC Opinion
4 Oct 2021
REC opinion
Further Information Favourable Opinion