WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)

NCT04701684 | Recruiting DMC FDA Device

• 1 other identifier: XCY607-130512
• Study Type: interventional
• Target: 594
• Locations: 10 countries
• Sites: 23

Brief Summary

The WE-TRUST study is a multi-center randomized clinical trial to assess the impact of a Direct to Angio Suite (DTAS) workflow on stroke patient outcomes.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• Distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up

  The difference in the distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up in the Target population to determine the performance of the DTAS triage imaging workflow involving Stroke CBCT reconstructions by the investigational device or SmartCT R3 in comparison to the conventional CT/MR triage imaging workflow. The 90 day mRS score will be evaluated by a blinded assessor of a pool of blinded assessors (i.e., a specialist with mRS certification) at the local hospital by performing a structured interview of the patient in person using the Rankin Focused Assessment (RFA) structured mRS questionnaire. If the subject is unable to return to the clinic for the day 90 ± 14 visit, a (video) call in which the mRS score is assessed by a blinded assessor is preferable to no assessment.

  90 ± 14 days follow-up

Secondary Outcomes (3)

• Median time measurements (door-to-arterial puncture time)

  Peri-procedural time

• Median time measurements (door-to-reperfusion time)

  Peri-procedural time

• Distribution of ordinal modified Rankin Scale (mRS) scores

  90 ± 14 days follow-up

Other Outcomes (31)

• Safety: Adverse events (mortality at 90 days)

  At 90 days post-procedure

• Safety: Adverse events (symptomatic ICH)

  At 24 (-12/+24) hours

• Safety: Adverse events (asymptomatic ICH)

  At 24 (-12/+24) hours

Study Arms (2)

Direct tot Angiography Suite (DTAS) triage workflow

EXPERIMENTAL

Device: Direct to Angio Suite (DTAS) Philips' CBCT triage

Conventional CT/MR triage workflow

ACTIVE COMPARATOR

Procedure: Conventional CT/MR triage

Interventions

Conventional CT/MR triage PROCEDURE

First a CT or MRI exam is acquired for triage. In case of an ischemic stroke the patient is then treated in an interventional suite.

Conventional CT/MR triage workflow

Direct to Angio Suite (DTAS) Philips' CBCT triage DEVICE

Stroke patients are diagnosed and treated (mechanical thrombectomy) in the same angio suite

Direct tot Angiography Suite (DTAS) triage workflow

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18 years of age or older, or of legal age to give informed consent per state or national law.
• Baseline NIHSS score obtained prior to randomization must be equal or higher than 10 points.
• Subjects with no significant pre-stroke functional disability (modified Rankin scale 0 - 2).
• Subjects suspected of acute ischemic stroke with an estimated arrival time at a stroke center (clinical investigational site participating in this study) \< 6 hours from symptom onset OR wake-up stroke with time last known well of \< 12 hours and symptoms discovered within 6 hours from arrival time at a stroke center. Symptom onset is defined as point in time the patient was last known well (at baseline).
• Informed consent obtained from patient or his or her legally designated representative (if locally required).
• Angiography suite immediately available.
• Endovascular treatment team immediately available (Neurologist, Neurointerventionalist, Anesthesiologist, Nursing, Technicians as per local standard practice)

You may not qualify if:

• Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0
• Known baseline platelet count \< 30.000/μL
• Baseline blood glucose of \< 50mg/dL (\< 2.78mmol/l)
• For patients receiving thrombolysis: severe, sustained hypertension (SBP \> 185 mm Hg or DBP \> 110 mm Hg). Note: If the blood pressure can be successfully reduced and maintained at the acceptable level using AHA/ASA guidelines recommended medication (including IV antihypertensive drips), the patient can be enrolled.
• Patients from a transfer center (Primary Stroke Center) with a CT/MR that is not required to be redone in the Comprehensive Stroke Center as per discretion of the physician or per local standards (e.g. CT/MR less than 90 minutes old).
• Patients in coma (NIHSS item of consciousness \>1) defined as totally unresponsive; responding only with reflexes or being areflexic (Intubated patients for transfer could be randomized only in case an NIHSS is obtained by a neurologist prior transportation).
• Patients with extreme vomiting
• Patients that are extremely agitated
• Seizures at stroke onset which would preclude obtaining a baseline NIHSS
• Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
• Patients acquired stroke while in-hospital
• History of life-threatening allergy (more than rash) to contrast medium
• Cerebral vasculitis
• Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be ≤2. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)
• Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas).

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (23)

Baptist Medical Center

Jacksonville, Florida, 32207, United States

RECRUITING

Grady Memorial Hospital/Emory University

Atlanta, Georgia, 30303, United States

NOT YET RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

La Sagrada Familia Clinic

José Hernández, Argentina

RECRUITING

UZ Brussels

Brussels, Belgium

RECRUITING

Hospital Geral de Fortaleza

Fortaleza, Brazil

RECRUITING

Hospital de Base

São José do Rio Preto, Brazil

NOT YET RECRUITING

Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba

Vitória, Brazil

RECRUITING

Hospices Civils de Lyon

Lyon, France

COMPLETED

CHU Montpellier

Montpellier, France

RECRUITING

Bicêtre Hospital

Paris, France

RECRUITING

University Hospital Bonn (UKB Universitätsklinikum Bonn)

Bonn, 53127, Germany

RECRUITING

Klinikum Kassel

Kassel, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein Lübeck

Lübeck, 23562, Germany

RECRUITING

Klinikum rechts der Isar der TU München

Munich, Germany

RECRUITING

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

COMPLETED

Haaglanden Medical Center

The Hague, Netherlands

WITHDRAWN

University Emergency Hospital Bucharest

Bucharest, Romania

NOT YET RECRUITING

Hospital Clinico San Carlos

Madrid, Moncloa - Aravaca, 28040, Spain

RECRUITING

Vall d'Hebron University Hospital

Barcelona, Spain

RECRUITING

Hospital Universitari Doctor Josep Trueta de Girona

Girona, Spain

RECRUITING

Hospital Virgen del Rocio

Seville, Spain

RECRUITING

İstanbul Aydin University medical park florya hospital

Istanbul, Turkey (Türkiye)

COMPLETED

Related Links

• WE-TRUST study information website

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Raul G Nogueira

  UPMC Stroke Institute, Pittsburgh

  PRINCIPAL INVESTIGATOR

• Marc Ribo

  Vall d'Hebron University Hospital, Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerrits

CONTACT

+31 6 55 48 29 31; carin.gerrits@philips.com

Eshuis

CONTACT

+31 6 28 73 92 80; peter.g.eshuis@philips.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: January 8, 2021
• Study Start: June 23, 2021
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); NL (2); DE (4); US (3); AR (1); FR (3); RO (1); TU (1); BE (1); BR (3)