Stroke, AcuteNCT04701684
WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)
A study testing Direct to Angio Suite (DTAS) Philips' CBCT triage and Conventional CT/MR triage in people with Stroke, Acute, run by Philips Clinical & Medical Affairs Global at 24 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Direct to Angio Suite (DTAS) Philips' CBCT triage and Conventional CT/MR triage
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 594 participants
- Where
- 24 sitesin 10 countries
- Study dates
- 23 Jun 2021to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Clinical exclusion criteria:
- 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).
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- 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).
- Patients with unstable clinical status who require emergent life support care
- Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
- Subject participates in a potentially confounding drug or device trial during the course of the study.
- Woman of childbearing potential who is known to be pregnant on admission.
- Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breast feeding woman)
- Subject is Philips employee or their family members residing with this Philips employee.
Trial locations and contacts
24 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
24 sites in 10 countries
Germany4 sites, 4 recruiting
- Recruiting
University Hospital Bonn (UKB Universitätsklinikum Bonn)
Bonn, 53127
Felix Bode
- Recruiting
Klinikum Kassel
Kassel
Christian Roth
Ralf Siekmann
- Recruiting
Universitätsklinikum Schleswig-Holstein Lübeck
Lübeck, 23562
Peter Schramm
Georg Royl
- Recruiting
Klinikum rechts der Isar der TU München
Munich
Tobias Boeckh-Behrens
Spain4 sites, 4 recruiting
- Recruiting
Vall d'Hebron University Hospital
Barcelona
Marc Ribo
- Recruiting
Hospital Universitari Doctor Josep Trueta de Girona
Girona
Mikel Terceño
Yolanda Silva
- Recruiting
Hospital Clinico San Carlos
Madrid, Moncloa - Aravaca, 28040
Manuel Moreu
Carlos Gomez Escalonilla
- Recruiting
Hospital Virgen del Rocio
Seville
Alejandro Gonzalez
Francisco Moniche
United States3 sites, 3 recruiting
- Not yet recruiting
Grady Memorial Hospital/Emory University
Atlanta, Georgia, 30303
Diogo Haussen
Raul Nogueira
- Recruiting
Baptist Medical Center
Jacksonville, Florida, 32207
Ricardo Hanel
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Seon Kyu Lee
Brazil3 sites, 3 recruiting
- Recruiting
Hospital Geral de Fortaleza
Fortaleza
Francisco Mont' Alverne
Fabricio Oliveira Lima
- Not yet recruiting
Hospital de Base
São José do Rio Preto
Raquel Hidalgo
- Recruiting
Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba
Vitória
Derval Pimentel
Leandro De Assis Barbosa
France3 sites, 2 recruiting
- Completed
Hospices Civils de Lyon
Lyon
- Recruiting
CHU Montpellier
Montpellier
Vincent Costalat
Caroline Arquizan
- Recruiting
Bicêtre Hospital
Paris
Laurent Spelle
Netherlands2 sites
- Completed
St. Antonius Ziekenhuis
Nieuwegein
- Withdrawn
Haaglanden Medical Center
The Hague
Turkey (Türkiye)2 sites, 1 recruiting
- Completed
İstanbul Aydin University medical park florya hospital
Istanbul
- Not yet recruiting
İstinye Üniversitesi Gaziosmanpaşa Hastanesi
Istanbul
Serdar Geyik
Sena Aksoy
Argentina1 site, 1 recruiting
- Recruiting
La Sagrada Familia Clinic
José Hernández
Pedro Lylyk
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussels
Brussels
Frans van den Bergh
Sylvie de Raedt
Romania1 site, 1 recruiting
- Recruiting
University Emergency Hospital Bucharest
Bucharest
Razvan Radu
Christina Tiu
About this study
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.
Read the detailed description
Outcomes for stroke patients are closely tied to how fast they receive treatment. Currently, when a possible stroke patient arrives at the emergency department, typically first a CT or MRI exam is acquired for stroke triage. In case of an ischemic stroke the patient is then treated in an interventional suite.
In the DTAS workflow stroke patients are diagnosed and treated in the interventional suite without interruption. The Cone-Beam CT (CBCT) capabilities of the interventional X-ray system are utilized to perform triage, directly followed by stroke treatment.
The primary objective of the WE-TRUST study is to demonstrate that the DTAS triage workflow involving CBCT results in superior patient outcome in ischemic stroke patients with confirmed Large Vessel Occlusion as compared to the conventional CT/MR triage workflow.
The WE-TRUST study will be running in 16+ sites to enroll 500+ patients globally.
- Conditions
- Stroke, Acute
- Being tested
- Direct to Angio Suite (DTAS) Philips' CBCT triage, Conventional CT/MR triage
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct to Angio Suite (DTAS) Philips' CBCT triageDevice
Stroke patients are diagnosed and treated (mechanical thrombectomy) in the same angio suite
Conventional CT/MR triageProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Direct tot Angiography Suite (DTAS) triage workflow | Experimental | Not described Receives: Device: Direct to Angio Suite (DTAS) Philips' CBCT triage |
| Conventional CT/MR triage workflow | Active comparator | Not described Receives: Procedure: Conventional CT/MR triage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 ± 14 days follow-up
Secondary outcomes (3)
Median time measurements (door-to-arterial puncture time)
Door-to-arterial puncture time: Time patient arrives at the Comprehensive Stroke Center door to the time the skin of the patient is touched to perform first arterial puncture.
Measured: Peri-procedural time
Median time measurements (door-to-reperfusion time)
Door-to-reperfusion time: Time patient arrives at the Comprehensive Stroke Center door to the time of successful vessel recanalization (eTICI ≥ 2b)
Measured: Peri-procedural time
Distribution of ordinal modified Rankin Scale (mRS) scores
The distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up in both arms in the Randomized population.
Measured: 90 ± 14 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start23 Jun 2021
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 594 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raul G Nogueira, Principal investigator, UPMC Stroke Institute, PittsburghMarc Ribo, Principal investigator, Vall d'Hebron University Hospital, Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701684
- Sponsor's protocol ID
- XCY607-130512
- Status last verified
- Sep 2026
- First submitted
- 21 Dec 2020
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)
- ClinicalTrials.gov ID
- NCT04701684
- Acronym / sponsor ID
- XCY607-130512
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 594 participants (estimated)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Outcomes for stroke patients are closely tied to how fast they receive treatment. Currently, when a possible stroke patient arrives at the emergency department, typically first a CT or MRI exam is acquired for stroke triage. In case of an ischemic stroke the patient is then treated in an interventional suite.
In the DTAS workflow stroke patients are diagnosed and treated in the interventional suite without interruption. The Cone-Beam CT (CBCT) capabilities of the interventional X-ray system are utilized to perform triage, directly followed by stroke treatment.
The primary objective of the WE-TRUST study is to demonstrate that the DTAS triage workflow involving CBCT results in superior patient outcome in ischemic stroke patients with confirmed Large Vessel Occlusion as compared to the conventional CT/MR triage workflow.
The WE-TRUST study will be running in 16+ sites to enroll 500+ patients globally.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct to Angio Suite (DTAS) Philips' CBCT triageStroke patients are diagnosed and treated (mechanical thrombectomy) in the same angio suite | Device | Direct tot Angiography Suite (DTAS) triage workflow |
| Conventional CT/MR triageFirst a CT or MRI exam is acquired for triage. In case of an ischemic stroke the patient is then treated in an interventional suite. | Procedure or surgery | Conventional CT/MR triage workflow |
Primary outcome
Distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up
Time frame: 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.
3 secondary outcomes
Median time measurements (door-to-arterial puncture time)
Time frame: Peri-procedural time
Median time measurements (door-to-reperfusion time)
Time frame: Peri-procedural time
Distribution of ordinal modified Rankin Scale (mRS) scores
Time frame: 90 ± 14 days follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- WE-TRUST study information websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raul G Nogueira principal investigator
UPMC Stroke Institute, Pittsburgh
Marc Ribo principal investigator
Vall d'Hebron University Hospital, Barcelona
24 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct to Angio Suite (DTAS) Philips' CBCT triage and Conventional CT/MR triage in people with Stroke, Acute, run by Philips Clinical & Medical Affairs Global at 24 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, Spain, United States, Brazil, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerrits (+31 6 55 48 29 31, carin.gerrits@philips.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up (time frame: 90 ± 14 days follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.