Philips WE-TRUST Trial of Direct-to-Angio Pathway for Stroke Expanded to France and the United States

July 18, 2023—Royal Philips announced that the first patients in France and the United States have been enrolled in the multicenter, prospective WE-TRUST randomized controlled trial. The patients were enrolled at the Bicêtre Hospital in Paris, France, and the Baptist Stroke & Cerebrovascular Center, a comprehensive stroke center in Jacksonville, Florida.

Philips advised that these milestones mark an important expansion of the trial, which was already being conducted in several European and South American countries. In July 2021, the company announced commencement of the trial with the initial patient enrolled at Vall d’Hebron University Hospital in Barcelona, Spain.

The company-sponsored WE-TRUST clinical trial aims to evaluate whether the Philips direct-to-angio suite (DTAS) workflow can improve outcomes for early time-window (< 6 hours after onset) stroke patients compared to the conventional method of obtaining diagnostic MR/CT scans before transfer to the angio suite.

WE-TRUST is an open-label, blinded-endpoint trial that aims to include 16 leading stroke sites and enroll > 500 patients across the United States, Brazil, Argentina, the Netherlands, Germany, France, Spain, and Turkey. More information is available on the study’s website, wetrust-study.com.

“Every second counts for acute stroke patients,” commented neurosurgeon Ricardo Hanel, MD, Director of the Baptist Neurological Institute, in Philips’ press release. “It is critically important to act quickly and treat them as soon as possible for better results and a better quality of life. By incorporating United States patients into the WE-TRUST trial, we aim to help provide data and outcomes that will inform clinical workflows that in turn (and more importantly) benefit patients across the globe.”

The company reported that the first patient treated in France had a severe stroke. The patient arrived directly to the hospital and went straight to the angio suite, where within 30 minutes Vanessa Chalumeau, MD, started the procedure to remove the blood clot in the patient’s brain. After the intervention, the patient’s condition improved significantly.

In Philips’s press release, interventional neuroradiologist Laurent Spelle, MD, stated, “By using the direct-to-angio approach, we were able to diagnose and treat this patient faster than conventional methods.”

Dr. Spelle, who is Chairman at Neuri, the Brain Vascular Center at Bicêtre Hospital, continued, “Our goal is to find more effective and efficient ways to diagnose, treat, and manage stroke, ultimately enhancing the quality of life for patients. By joining WE-TRUST, we can help build the clinical evidence for the DTAS workflow, a new treatment approach that has great potential to improve patient outcomes.”

Philips advised that its DTAS approach combines stroke diagnosis and treatment in a single angio suite session. DTAS is enabled by a cone-beam CT imaging tool that is integrated into interventional angio suite systems, such as Philips’ Azurion image-guided therapy system. The DTAS approach can potentially reduce the time to treatment for early time-window (< 6 hours after onset) stroke patients.

As noted in the press release, Philips announced on June 14 that the results of a health economics analysis published by Manuel Requena, MD, et al online in the Journal of NeuroInterventional Surgery showed that the Philips DTAS pathway for stroke patients can save more than US$3,000 per patient.