Philips
(NYSE: PHG)
announced today that its WE-TRUST clinical trial enrolled its first patients in France and the U.S.
The trial aims to evaluate whether a direct-to-angio suite (DTAS) workflow can improve outcomes for early time-window stroke patients. It compares this method to the conventional approach that uses a diagnostic MR/CT scan before transfer to the angio suite.
The Bicêtre Hospital in Paris successfully recruited the first French patient in the WE-TRUST trial. The Baptist Stroke & Cerebrovascular Center in Jacksonville, Florida, successfully enrolled the first patient in the U.S. Philips said these enrollments mark the important international expansion of the WE-TRUST trial. The company already has patients enrolled in Europe and South America, including in Spain, Turkey, Germany, Brazil, The Netherlands and Argentina.
In France, the first treated patient had a severe stroke and arrived directly at the hospital. The patient went straight to the angio suite where. There, within 30 minutes, Dr. Vanessa Chalumeau began the procedure to remove the blood clot in their brain. After, the patient’s condition improved significantly, Philips said in a news release.
“By using the direct-to-angio approach we were able to diagnose and treat this patient faster than conventional methods,” said Dr.Laurent Spelle, interventional neuroradiologist and chair at NEURI Brain Vascular Center at Bicêtre Hospital. “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 direct-to-angio suite (DTAS) workflow, a new treatment approach that has great potential to improve patient outcomes.”
More about the Philips WE-TRUST clinical trial
WE-TRUST investigates the clinical impact of the DTAS approach combining stroke diagnosis and treatment in a single angio suite session.
Philips enables the DTAS pathway with its cone-beam CT imaging tool. Cone-beam CT integrates into interventional angio suite systems like the image-guided Azurion platform. The method could potentially reduce the time to treatment for early time-window stroke patients (less than six hours post-onset).
WE-TRUST, a multicenter, prospective, randomized controlled trial aims to engage 16 stroke sites and enroll more than 500 patients. It follows Philips’ ANGIOCAT trial that recently produced positive data for the DTAS suite.
“At Philips, we believe that implementing a Direct to Angio Suite workflow, where suspected stroke patients undergo diagnosis and treatment in a single room, holds the promise of saving critical minutes and preserving invaluable brain function,” said Dr. Atul Gupta, chief medical officer for image-guided therapy at Philips. “While the outcomes of numerous single-center studies have already validated this belief, it is essential to conduct a multicenter clinical trial of the magnitude and scope of WE-TRUST to ascertain the DTAS approach as a benchmark in stroke care.”