The trial will assess the efficacy of the Direct to Angio Suite workflow to improve outcomes in early time-window stroke patients
Philips has enrolled first patient in Direct to Angio Suite workflow trial. (Credit: Koninklijke Philips N.V.)
Health technology company Royal Philips has recruited the first patient in the WE-TRUST study of the Direct to Angio Suite workflow platform.
The WE-TRUST (workflow optimisation to reduce time to endovascular reperfusion for ultra-fast stroke treatment) trial will assess the clinical impact of the workflow platform via a special scan in the angio suite developed by Philips.
The multicentre and randomised study will evaluate the efficacy of the Direct to Angio Suite workflow to improve outcomes in early time-window stroke patients.
Philips’ Direct to Angio Suite workflow uses improved cone-beam computed tomography (CBCT) to enhance image quality, as well as facilitate triage of patients.
The specially designed algorithms will be used by the investigational device to reconstruct the stroke CBCT images. It will also use filters to reduce artifacts caused by patient motion, bone beam hardening and metal objects.
The WE-TRUST principal investigator Dr Raul Nogueira said: “After suffering a stroke, fast time to treatment is paramount to giving patients the best possible outcomes. What we will learn about improving time to treatment in the WE-TRUST trial has the potential to significantly improve how acute stroke patients are diagnosed and treated.”
Philip will recruit over 560 patients in the controlled, open-label and blinded-endpoint trial at 15 strokes sites in the US, Brazil, Argentina, the Netherlands, France, Germany, Spain and Turkey.
The company is planning to complete the trial by 2023.
Philips will primarily conduct the study on its Azurion image-guided therapy system, which is mostly used for interventional procedures.
According to the company, the WE-TRUST trial’s primary endpoint is clinical outcome measured by the patients’ functional status (mRS) three months after the procedure.
Philips image-guided therapy chief medical officer Dr Atul Gupta said: “The WE-TRUST study is a key milestone, building on Philips’ leading position in image-guided therapy and our strong global network of clinical partnerships.
“It adds to our deep commitment to further optimize stroke workflow, remove the hurdles to fast, decisive treatment, and improve stroke outcomes.”
Last month, Philips commenced enrolling the first patients in DEFINE GPS, a global, multi-centre, prospective and randomised controlled study.