An interventional study of Direct to Angio Suite (DTAS) Philips' CBCT triage and Conventional CT/MR triage in Stroke, Acute, sponsored by Philips Clinical & Medical Affairs Global. Recruiting at 24 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Philips Clinical & Medical Affairs Global (part of Philips) · Not applicable, Interventional, and Diagnostic
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 594 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Philips Clinical & Medical Affairs Global is the lead sponsor of 85 studies on the registry; 25 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 12 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Clinical exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Direct to Angio Suite (DTAS) Philips' CBCT triage
Procedure: Conventional CT/MR triage
Stroke patients are diagnosed and treated (mechanical thrombectomy) in the same angio suite
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.
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.
Time frame: 90 ± 14 days follow-up
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.
Time frame: 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)
Time frame: 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.
Time frame: 90 ± 14 days follow-up
Safety: Adverse events (mortality at 90 days)
Mortality and stroke-related mortality
Time frame: At 90 days post-procedure
Safety: Adverse events (symptomatic ICH)
All intracranial hemorrhages will be classified by the blinded Core Lab using the Heidelberg Bleeding Classification. Symptomatic ICH will be defined as per a modified SITS-MOST definition \[31\]: Symptomatic intracranial hemorrhage is defined as local or remote parenchymal hemorrhage type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage on the 24 (-12/+24) hours post-treatment imaging scan, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline, or from the lowest NIHSS value between baseline and 24 (-12/+24) hours after randomization, or leading to death.
Time frame: At 24 (-12/+24) hours
Safety: Adverse events (asymptomatic ICH)
All intracranial hemorrhages will be classified (blinded) by using the Heidelberg Bleeding Classification. All the intracranial hemorrhages which are not symptomatic, are classified as asymptomatic.
Time frame: At 24 (-12/+24) hours
Safety: Adverse events (other)
including information of the seriousness, treatment needed, resolution and relevant judgment concerning the causal relationship with the investigational device, SmartCT R3, comparator (CT/MR), or procedure will be summarized for safety information.
Time frame: From start of enrollment until hospital discharge (e.g. up to 5 days)
Safety: Adverse Device Effects
including information of the seriousness, treatment needed, resolution and relevant judgment concerning the causal relationship with the investigational devices, released SmartCT R3 product or procedure will be summarized for safety information.
Time frame: From start of enrollment until hospital discharge (e.g. up to 5 days)
Safety: Number of participants with Device Deficiencies that could have led to Serious Adverse Event
including any corrective actions taken during the study, if any, will be summarized for safety information.
Time frame: From start of enrollment until hospital discharge (e.g. up to 5 days)
Exploratory: Median time measurements (door-to-randomization time)
Door-to-randomization time: Time patient arrives at the Comprehensive Stroke Center door to the time of randomization
Time frame: Peri-procedural time
Exploratory: Median time measurements (door-to-imaging time)
Door-to-imaging time: Time patient arrives at the Comprehensive Stroke Center door to the time of initial triage imaging acquisition (i.e. non-contrast CBCT or CT/MR)
Time frame: Peri-procedural time
Exploratory: Median time measurements (randomization-to-imaging time)
Randomization-to-imaging time: Time of randomization to the time of initial triage imaging acquisition (i.e. non-contrast CBCT or CT/MR)
Time frame: Peri-procedural time
Exploratory: Median time measurements (randomization-to-puncture time)
Randomization-to-puncture time: Time of randomization to the time the skin of the patient is touched to perform first arterial puncture
Time frame: Peri-procedural time
Exploratory: Median time measurements (door-to-thrombolytics administration time)
Door-to-thrombolytics administration time: Time patient arrives at the CSC door to the time of start of thrombolytics administration.
Time frame: Peri-procedural time
Exploratory: Median time measurements (onset-to-door time)
Onset-to-door time: Time patient last seen well to the time the patient arrives at the Comprehensive Stroke Center door
Time frame: Peri-procedural time
Exploratory: Median time measurements (onset-to-arterial puncture time)
Onset-to-arterial puncture time: Time patient last seen well to the time the skin of the patient is touched to perform first arterial puncture
Time frame: Peri-procedural time
Exploratory: Median time measurements (onset-to-successful reperfusion (eTICI ≥ 2b) time)
Onset-to-successful reperfusion (eTICI ≥ 2b) time: Time patient last seen well to the time of successful vessel recanalization (based on angiogram).
Time frame: Peri-procedural time
Exploratory: Median time measurements (Emergency Medical Services call-to-door time)
Emergency Medical Services call-to-door time: Time from the call to Emergency Medical Services to the time the patient arrives at the Comprehensive Stroke Center door (total ambulance service time)
Time frame: Peri-procedural time
Exploratory: Median time measurements (Comprehensive Stroke Center notification call-to-door time)
Comprehensive Stroke Center notification call-to-door time: Time from notification call to the Comprehensive Stroke Center stroke team to the time the patient arrives at the Comprehensive Stroke Center door
Time frame: Peri-procedural time
Exploratory: Median time measurements (imaging-to-thrombolytics administration time)
Imaging-to-thrombolytics administration time: Time from initial triage imaging acquisition (i.e. non-contrast CBCT or CT/MR) to the time of start of thrombolytics administration.
Time frame: Peri-procedural time
Exploratory: Median time measurements (imaging-to-arterial puncture time)
Imaging-to-arterial puncture time: Time from initial triage imaging acquisition (i.e. non-contrast CBCT or CT/MR) to the time the skin of the patient is touched to perform first arterial puncture
Time frame: Peri-procedural time
Exploratory: Median time measurements (Door-to-device deployment (first pass) time)
Door-to-device deployment (first pass) time: Time patient arrives at the CSC door to the time of device deployment (first pass).
Time frame: Peri-procedural time
Exploratory: Median time measurements (imaging-to-successful reperfusion (eTICI ≥ 2b) time)
Imaging-to-successful reperfusion (eTICI ≥ 2b) time: Time from initial triage imaging acquisition (i.e. non-contrast CBCT or CT/MR) to time of successful vessel recanalization (based on angiogram).
Time frame: Peri-procedural time
Exploratory: Median time measurements (arterial puncture-to-successful reperfusion (eTICI ≥ 2b) time)
Arterial puncture-to-successful reperfusion (eTICI ≥ 2b) time: Time the skin of the patient is touched to perform first arterial puncture to the time of successful vessel recanalization.
Time frame: Peri-procedural time
Exploratory: Median time measurements (arterial puncture-to-end-of-EVT procedure (catheter out) time)
Arterial puncture-to-end-of-EVT procedure (catheter out) time: Time the skin of the patient is touched to perform first arterial puncture to the time of the catheter is taken out (total EVT procedure time)
Time frame: Peri-procedural time
Exploratory: Degree of disability (other clinical outcome)
Defined as modified Rankin Scale score (scores 0-6) distribution at discharge or at 5-7 days post-procedure, whichever comes first, and at 90 ± 14 days.
Time frame: At discharge or 5-7 days post-procedure, and at 90 ± 14 days post-procedure
Exploratory: NIHSS (other clinical outcome)
The National Institutes of Health Stroke Scale is a tool used to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0
Time frame: At admission (baseline), 24(-12/+24) hours after randomization, discharge or at 5-7 days post-procedure, whichever comes; and at 90 ± 14 days post-procedure
Exploratory: Functional independence (other clinical outcome)
Functional independence defined as mRS ≤ 2 at 90 days. The scale runs from 0-6, running from perfect health without symptoms (0) to death (6).
Time frame: At 90 ± 14 days post-procedure
Exploratory: UW-mRS (other clinical outcome)
Utility-Weighted modified Ranking Scale. The scale runs from 0-6, running from perfect health without symptoms (0) to death (6).
Time frame: At 90 ± 14 days post-procedure
Exploratory: Dichotomized mRS score (other clinical outcome)
Dichotomized mRS score (0-3 versus 4-6). The scale runs from 0-6, running from perfect health without symptoms (0) to death (6).
Time frame: At 90 ± 14 days post-procedure
Exploratory: Infarct volume (other clinical outcome)
Infarct volume evaluated on CT or MRI
Time frame: At 24 (-12/+24) hours post-procedure
Exploratory: Dramatic early favorable response (other clinical outcome)
Defined as an NIHSS score of 0-2 or NIHSS improvement ≥ 8 points. The National Institutes of Health Stroke Scale is a tool used to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0
Time frame: At 24 (-12/+24) hours after randomization
Exploratory: Successful vessel recanalization (other clinical outcome)
Defined as expanded Thrombolysis in Cerebral Infarction) (eTICI) grade 2b, 2c or 3 on the post-procedure angiogram
Time frame: At the end of the endovascular procedure
Exploratory: X-ray radiation exposure (other clinical outcome)
Total X-ray Radiation Exposure measured as effective dose (mSv).
Time frame: On day 1
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Plan to share: No
Started Jun 2021 (actual). Primary completion is estimated for Apr 2027, 69 months after the start.
Of 144 industry-sponsored interventional studies with no phase under Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 69 months is above that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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