Royal Philips’ Direct to Angio Suite to Improve Stroke Outcomes Evaluated in WE-TRUST Trial

July 7, 2021—Royal Philips announced the beginning of the WE-TRUST randomized controlled trial to assess if the company’s Direct to Angio Suite workflow can improve outcomes for early time-window stroke patients (< 6 hours after stroke onset). The first patient was enrolled in the study at Vall d’Hebron University Hospital in Barcelona, Spain.

The WE-TRUST trial of “workflow optimization to reduce time to endovascular reperfusion for ultrafast stroke treatment” will study the clinical impact of the Direct to Angio Suite approach, enabled by a special scan in the angio suite.

This multicenter, prospective, randomized, controlled, open-label, blinded-endpoint trial is intended to take place at 15 leading strokes sites and aims to enroll > 560 patients in the United States, Brazil, Argentina, the Netherlands, France, Germany, Spain, and Turkey. The trial is anticipated to be completed by 2023.

According to the company, the Direct to Angio Suite approach combines stroke diagnosis and subsequent treatment in the same angio suite, which the study will compare to the conventional workflow of diagnosing patients for treatment in the CT or MRI suite and then treating them in a separate angio suite. The Direct to Angio approach can potentially reduce the time to treatment for early-window stroke patients.

Philips stated that Direct to Angio Suite workflow is enabled by an advanced brain scan in the angio suite that is developed by Philips. The scan uses improved cone-beam CT to improve image quality and facilitate triage of patients. This investigational device reconstructs the stroke cone-beam CT images using specially designed algorithms and filters to reduce artifacts caused by patient motion, bone beam hardening, and metal objects.

The trial will primarily be carried out on Philips’s Azurion image-guided therapy system. The primary endpoint of the WE-TRUST trial is clinical outcome measured by the patients’ functional status at 3 months after the procedure. More information about the study can be found online at wetrust-study.com.

Raul Nogueira, Director, Neuroendovascular Service Marcus Stroke and Neuroscience Center at Grady Health in Atlanta, Georgia, serves as principal investigator of WE-TRUST. Marc Ribó, MD, is coprincipal investigator of WE-TRUST. He is an interventional neurologist at the Vall d’Hebron University Hospital and researcher at the Stroke Research group at the Vall d’Hebron Research Institute in Barcelona, Spain.

“After suffering a stroke, fast time to treatment is paramount to giving patients the best possible outcomes,” commented Dr. Nogueira in Philips’ press release. “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. With the help of an advanced brain scan technology in the angio suite, for example, we intend to eliminate the need for conventional CT or MRI scans for stroke triage in select patients to save valuable time.”

Dr. Ribó added, “In a single-center randomized clinical trial in our center, the Direct to Angio Suite workflow has shown a significant improvement in clinical outcomes in patients who suffered a stroke. With the updated stroke cone-beam CT investigational device we can better facilitate triage of patients through improved image quality.”