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

March 3, 2026 updated by: Philips Clinical & Medical Affairs Global
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
594

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Argentina
      • José Hernández, Argentina
        • Recruiting
        • La Sagrada Familia Clinic
        • Contact:
          • Pedro Lylyk
  • Belgium
      • Brussels, Belgium
        • Recruiting
        • UZ Brussels
        • Contact:
          • Frans van den Bergh
        • Contact:
          • Sylvie de Raedt
  • Brazil
      • Fortaleza, Brazil
        • Recruiting
        • Hospital Geral de Fortaleza
        • Contact:
          • Francisco Mont' Alverne
        • Contact:
          • Fabricio Oliveira Lima
      • São José do Rio Preto, Brazil
        • Not yet recruiting
        • Hospital de Base
        • Contact:
          • Raquel Hidalgo
      • Vitória, Brazil
        • Recruiting
        • Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba
        • Contact:
          • Derval Pimentel
        • Contact:
          • Leandro De Assis Barbosa
  • France
      • Lyon, France
        • Completed
        • Hospices Civils de Lyon
      • Montpellier, France
        • Recruiting
        • CHU Montpellier
        • Contact:
          • Caroline Arquizan
        • Contact:
          • Vincent Costalat
      • Paris, France
        • Recruiting
        • Bicetre Hospital
        • Contact:
          • Laurent Spelle
  • Germany
      • Bonn, Germany, 53127
        • Recruiting
        • University Hospital Bonn (UKB Universitätsklinikum Bonn)
        • Contact:
          • Felix Bode
      • Kassel, Germany
        • Recruiting
        • Klinikum Kassel
        • Contact:
          • Christian Roth
        • Contact:
          • Ralf Siekmann
      • Lübeck, Germany, 23562
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein Lübeck
        • Contact:
          • Peter Schramm
        • Contact:
          • Georg Royl
      • Munich, Germany
        • Recruiting
        • Klinikum rechts der Isar der TU München
        • Contact:
          • Tobias Boeckh-Behrens
  • Netherlands
      • Nieuwegein, Netherlands
        • Completed
        • St. Antonius Ziekenhuis
      • The Hague, Netherlands
        • Withdrawn
        • Haaglanden Medical Center
  • Romania
      • Bucharest, Romania
        • Not yet recruiting
        • University Emergency Hospital Bucharest
        • Contact:
          • Razvan Radu
        • Contact:
          • Christina Tiu
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Vall d'Hebron University Hospital
        • Contact:
          • Marc Ribo
      • Girona, Spain
        • Recruiting
        • Hospital Universitari Doctor Josep Trueta de Girona
        • Contact:
          • Mikel Terceño
        • Contact:
          • Yolanda Silva
      • Seville, Spain
        • Recruiting
        • Hospital Virgen Del Rocio
        • Contact:
          • Alejandro Gonzalez
        • Contact:
          • Francisco Moniche
    • Moncloa - Aravaca
      • Madrid, Moncloa - Aravaca, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
          • Manuel Moreu
        • Contact:
          • Carlos Gomez Escalonilla
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Completed
        • İstanbul Aydin University medical park florya hospital
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist Medical Center
        • Contact:
          • Ricardo Hanel
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Not yet recruiting
        • Grady Memorial Hospital/Emory University
        • Contact:
          • Diogo Haussen
        • Contact:
          • Raul Nogueira
    • New York
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
          • Seon Kyu Lee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Direct tot Angiography Suite (DTAS) triage workflow
Device: Direct to Angio Suite (DTAS) Philips' CBCT triage
Stroke patients are diagnosed and treated (mechanical thrombectomy) in the same angio suite
Active Comparator: Conventional CT/MR triage workflow
Procedure: Conventional CT/MR triage
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
90 ± 14 days follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Median time measurements (door-to-arterial puncture time)
Time Frame: Peri-procedural 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.
Peri-procedural time
Median time measurements (door-to-reperfusion time)
Time Frame: Peri-procedural time
Door-to-reperfusion time: Time patient arrives at the Comprehensive Stroke Center door to the time of successful vessel recanalization (eTICI ≥ 2b)
Peri-procedural time
Distribution of ordinal modified Rankin Scale (mRS) scores
Time Frame: 90 ± 14 days follow-up
The distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up in both arms in the Randomized population.
90 ± 14 days follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety: Adverse events (mortality at 90 days)
Time Frame: At 90 days post-procedure
Mortality and stroke-related mortality
At 90 days post-procedure
Safety: Number of participants with Device Deficiencies that could have led to Serious Adverse Event
Time Frame: From start of enrollment until hospital discharge (e.g. up to 5 days)
including any corrective actions taken during the study, if any, will be summarized for safety information.
From start of enrollment until hospital discharge (e.g. up to 5 days)
Exploratory: Median time measurements (door-to-randomization time)
Time Frame: Peri-procedural time
Door-to-randomization time: Time patient arrives at the Comprehensive Stroke Center door to the time of randomization
Peri-procedural time
Exploratory: Median time measurements (door-to-imaging time)
Time Frame: Peri-procedural 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)
Peri-procedural time
Exploratory: Median time measurements (randomization-to-imaging time)
Time Frame: Peri-procedural time
Randomization-to-imaging time: Time of randomization to the time of initial triage imaging acquisition (i.e. non-contrast CBCT or CT/MR)
Peri-procedural time
Exploratory: Median time measurements (randomization-to-puncture time)
Time Frame: Peri-procedural time
Randomization-to-puncture time: Time of randomization to the time the skin of the patient is touched to perform first arterial puncture
Peri-procedural time
Exploratory: Median time measurements (door-to-thrombolytics administration time)
Time Frame: Peri-procedural time
Door-to-thrombolytics administration time: Time patient arrives at the CSC door to the time of start of thrombolytics administration.
Peri-procedural time
Exploratory: Median time measurements (onset-to-door time)
Time Frame: Peri-procedural time
Onset-to-door time: Time patient last seen well to the time the patient arrives at the Comprehensive Stroke Center door
Peri-procedural time
Exploratory: Median time measurements (onset-to-arterial puncture time)
Time Frame: Peri-procedural 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
Peri-procedural time
Exploratory: Median time measurements (onset-to-successful reperfusion (eTICI ≥ 2b) time)
Time Frame: Peri-procedural time
Onset-to-successful reperfusion (eTICI ≥ 2b) time: Time patient last seen well to the time of successful vessel recanalization (based on angiogram).
Peri-procedural time
Exploratory: Median time measurements (Emergency Medical Services call-to-door time)
Time Frame: Peri-procedural 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)
Peri-procedural time
Exploratory: Median time measurements (Comprehensive Stroke Center notification call-to-door time)
Time Frame: Peri-procedural 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
Peri-procedural time
Exploratory: Median time measurements (imaging-to-thrombolytics administration time)
Time Frame: Peri-procedural 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.
Peri-procedural time
Exploratory: Median time measurements (imaging-to-arterial puncture time)
Time Frame: Peri-procedural 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
Peri-procedural time
Exploratory: Median time measurements (Door-to-device deployment (first pass) time)
Time Frame: Peri-procedural time
Door-to-device deployment (first pass) time: Time patient arrives at the CSC door to the time of device deployment (first pass).
Peri-procedural time
Exploratory: Median time measurements (imaging-to-successful reperfusion (eTICI ≥ 2b) time)
Time Frame: Peri-procedural 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).
Peri-procedural time
Exploratory: Median time measurements (arterial puncture-to-successful reperfusion (eTICI ≥ 2b) time)
Time Frame: Peri-procedural 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.
Peri-procedural time
Exploratory: Degree of disability (other clinical outcome)
Time Frame: At discharge or 5-7 days post-procedure, and at 90 ± 14 days post-procedure
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.
At discharge or 5-7 days post-procedure, and at 90 ± 14 days post-procedure
Exploratory: Functional independence (other clinical outcome)
Time Frame: At 90 ± 14 days post-procedure
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).
At 90 ± 14 days post-procedure
Exploratory: UW-mRS (other clinical outcome)
Time Frame: At 90 ± 14 days post-procedure
Utility-Weighted modified Ranking Scale. The scale runs from 0-6, running from perfect health without symptoms (0) to death (6).
At 90 ± 14 days post-procedure
Exploratory: Dichotomized mRS score (other clinical outcome)
Time Frame: At 90 ± 14 days post-procedure
Dichotomized mRS score (0-3 versus 4-6). The scale runs from 0-6, running from perfect health without symptoms (0) to death (6).
At 90 ± 14 days post-procedure
Exploratory: Infarct volume (other clinical outcome)
Time Frame: At 24 (-12/+24) hours post-procedure
Infarct volume evaluated on CT or MRI
At 24 (-12/+24) hours post-procedure
Exploratory: Successful vessel recanalization (other clinical outcome)
Time Frame: At the end of the endovascular procedure
Defined as expanded Thrombolysis in Cerebral Infarction) (eTICI) grade 2b, 2c or 3 on the post-procedure angiogram
At the end of the endovascular procedure
Exploratory: X-ray radiation exposure (other clinical outcome)
Time Frame: On day 1
Total X-ray Radiation Exposure measured as effective dose (mSv).
On day 1
Safety: Adverse events (symptomatic ICH)
Time Frame: At 24 (-12/+24) hours
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.
At 24 (-12/+24) hours
Safety: Adverse events (asymptomatic ICH)
Time Frame: At 24 (-12/+24) hours
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.
At 24 (-12/+24) hours
Safety: Adverse events (other)
Time Frame: From start of enrollment until hospital discharge (e.g. up to 5 days)
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.
From start of enrollment until hospital discharge (e.g. up to 5 days)
Safety: Adverse Device Effects
Time Frame: From start of enrollment until hospital discharge (e.g. up to 5 days)
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.
From start of enrollment until hospital discharge (e.g. up to 5 days)
Exploratory: Median time measurements (arterial puncture-to-end-of-EVT procedure (catheter out) time)
Time Frame: Peri-procedural 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)
Peri-procedural time
Exploratory: NIHSS (other clinical outcome)
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
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
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: Dramatic early favorable response (other clinical outcome)
Time Frame: At 24 (-12/+24) hours after randomization
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
At 24 (-12/+24) hours after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philips Clinical & Medical Affairs Global

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc Ribo, Vall d'Hebron University Hospital, Barcelona
  • Principal Investigator: Raul G Nogueira, UPMC Stroke Institute, Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XCY607-130512

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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