July 7, 2021
- First patient enrolled in global multi-center randomized controlled trial with 564 patients at 15 sites comparing the impact of the Direct to Angio Suite workflow (diagnosis and treatment in the angio suite) to the conventional workflow (diagnosis in the CT or MRI suite followed by treatment in the angio suite) on stroke patient outcomes
- WE-TRUST trial to provide most comprehensive assessment to date with the help of an advanced brain scan technology in the angio suite for more effective and efficient stroke patient outcomes.
Amsterdam, the Netherlands -Royal Philipsworkflow can improve outcomes for early time-window stroke patients (less than six hours after stroke onset).
The WE-TRUST.
"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," said Dr. Raul Nogueira, Director, Neuroendovascular Service Marcus Stroke and Neuroscience Center at Grady Health in Atlanta, Georgia, and WE-TRUST Principal Investigator. "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."
This multicenter, prospective, randomized, controlled, open-label, blinded-endpoint trial is intended to take place at 15 leading strokes sites and aims to enroll more than 560 patients across the United States, Brazil, Argentina, the Netherlands, France, Germany, Spain and Turkey. The trial is anticipated to be completed by 2023.
Stroke is the leading cause of disability
Globally, 1 in 4 adults over the age of 25 will have a stroke in their lifetime [1], and data show that 1 in 200 people are stroke survivors, making acute stroke the second leading cause of death and a leading cause of serious long-term disability [2]. Currently, when a possible stroke patient arrives at the emergency department, they typically first undergo a CT or MRI exam and, in the case of an ischemic stroke, are then treated in an interventional suite. Outcomes for stroke patients are closely tied to how quickly they receive treatment: every 30 minutes' delay before treatment reduces the chance of a good outcome by 14% [3], and every hour of delay ages the brain by 3.6 years compared to a normally aging brain [4]. Various single-center studies have already shown that a Direct to Angio Suite workflow can result in time-savings up to 54 minutes with improved patient outcomes after 90 days [5].
Advanced brain scan in the angio suite
The Direct to Angio Suite workflow is enabled by an advanced brain scan in the angio suite, developed by Philips, that uses improved cone-beam computed tomography (CBCT) to improve image quality and facilitate triage of patients. This investigational device reconstructs the stroke CBCT images using specially designed algorithms and filters to reduce artifacts caused by patient motion, bone beam hardening and metal objects.
"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," said Dr. Marc Ribó, WE-TRUST co-Principal Investigator, Interventional Neurologist at the Vall d'Hebron University Hospital and researcher at the Stroke Research group at the Vall d'Hebron Research Institute (VHIR). "With the updated Stroke CBCT investigational device we can better facilitate triage of patients through improved image quality."
"We are very excited to initiate this multicenter study, partnering with leading stroke centers and physicians to innovate the diagnosis and treatment of stroke patients," said Dr. Atul Gupta, Chief Medical Officer for Image Guided Therapy at Philips. "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."
The trial will primarily be carried out on Philips Image Guided Therapy System - Azurion- the company's leading system for interventional procedures. The primary endpoint of the WE-TRUST trial is clinical outcome measured by the patients' functional status.
[1] https://www.world-stroke.org/world-stroke-day-campaign/why-stroke-matters/learn-about-stroke
[2] Centers for Disease Control and prevention); Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, et al. Heart disease and stroke statistics-2020 update: a report from the American Heart Associationexternal icon. Circulation. 2020;141)
[3] Mazighi, M. et al. Impact of Onset-to-Reperfusion Time on Stroke Mortality. Circulation 127, 1980-1985, doi:10.1161/circulationaha.112.000311)
[4] Saver, J. L. )
[5] Mendez, B., et al., Direct Transfer to Angio-Suite to Reduce Workflow Times and Increase Favorable Clinical Outcome. Stroke, 2018. 49)
For further information, please contact:
Joost Maltha
Philips Global Press Office
Tel: +31 610 558 116
Email: joost.maltha@philips.com
Twitter: JoostMaltha
Fabienne van der Feer
Philips Image Guided Therapy
Tel: +31 622 698 001
Email: fabienne.van.der.feer@philips.com
Twitter: FC_Feer
About Royal Philips
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Attachments
- Vall d'Hebron University Hospital Spain (https://ml-eu.globenewswire.com/Resource/Download/ef35e259-5b27-4554-a1b1-aaab9b7e2682)
- Clinical Team Vall d'Hebron (https://ml-eu.globenewswire.com/Resource/Download/d5cd1d96-440f-4e75-968b-b81c9a99e911)
- WE-TRUST logo (https://ml-eu.globenewswire.com/Resource/Download/1486a151-045c-4edf-afb4-08d1439cc3e1)
