WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04701684 |
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Recruitment Status :
Recruiting
First Posted : January 8, 2021
Last Update Posted : January 29, 2024
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Sponsor:
Philips Clinical & Medical Affairs Global
Information provided by (Responsible Party):
Philips Clinical & Medical Affairs Global
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stroke, Acute | Device: Direct to Angio Suite (DTAS) Philips' CBCT triage Procedure: Conventional CT/MR triage | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 564 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment) |
| Actual Study Start Date : | June 23, 2021 |
| Estimated Primary Completion Date : | December 1, 2024 |
| Estimated Study Completion Date : | December 1, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| 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. |
Primary Outcome Measures :
- 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 ITT population to determine the performance of the DTAS triage imaging workflow involving Stroke CBCT reconstructions by the investigational device 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 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.
Secondary Outcome Measures :
- 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.
- 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)
- 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 ITD population to determine the difference of the DTAS triage imaging workflow involving Stroke CBCT reconstructions by the investigational device in comparison to the conventional CT/MR triage imaging workflow in all randomized suspected stroke patients
Other Outcome Measures:
- Safety: Adverse events (mortality at 90 days) [ Time Frame: At 90 days post-procedure ]Mortality and stroke-related mortality
- Safety: Adverse events (symptomatic ICH) [ Time Frame: At 24 (-12/+24) hours ]All intracerebral 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 intracerebral 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 h, or leading to death.
- Safety: Adverse events (asymptomatic ICH) [ Time Frame: At 24 (-12/+24) hours ]All intracerebral hemorrhages will be classified (blinded) by using the Heidelberg Bleeding Classification. All the intracerebral hemorrhages which are not symptomatic, are classified as asymptomatic.
- 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, market released CBCT acquisition, comparator (CT/MR) or procedure will be summarized for safety information.
- 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 or procedure will be summarized for safety information.
- 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.
- 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
- 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)
- 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)
- 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
- 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.
- 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
- 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
- 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).
- 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)
- 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
- 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.
- 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
- 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).
- 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).
- 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.
- Exploratory: Median time measurements (arterial puncture-to-skin closure time) [ Time Frame: Peri-procedural time ]Arterial puncture-to-skin closure time: Time the skin of the patient is touched to perform first arterial puncture to the time of skin closure (total EVT procedure 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.
- Exploratory: NIHSS (other clinical outcome) [ Time Frame: At admission (baseline), 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
- 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).
- 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).
- 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).
- Exploratory: Infarct volume (other clinical outcome) [ Time Frame: At 24 (-12/+24) hours post-procedure ]Infarct volume evaluated on CT or MRI
- Exploratory: Dramatic early favorable response (other clinical outcome) [ Time Frame: At 24 (-12/+24) hours ]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
- 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
- Exploratory: X-ray radiation exposure (other clinical outcome) [ Time Frame: On day 1 ]Total X-ray Radiation Exposure measured as effective dose (mSv).
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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. 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, Neurointerventionist, 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 then 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04701684
Contacts
| Contact: Gerrits | +31 6 55 48 29 31 | carin.gerrits@philips.com | |
| Contact: Eshuis | +31 6 28 73 92 80 | peter.g.eshuis@philips.com |
Locations
| United States, Florida | |
| Baptist Medical Center | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Ricardo Hanel | |
| United States, Georgia | |
| Grady Memorial Hospital/Emory University | Not yet recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: Diogo Haussen | |
| Contact: Raul Nogueira | |
| United States, New York | |
| Montefiore Medical Center | Not yet recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Lee | |
| Argentina | |
| La Sagrada Familia Clinic | Recruiting |
| José Hernández, Argentina | |
| Contact: Pedro Lylyk | |
| Brazil | |
| Hospital Geral de Fortaleza | Recruiting |
| Fortaleza, Brazil | |
| Contact: Francisco Mont' Alverne | |
| Contact: Fabricio Oliveira Lima | |
| Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba | Recruiting |
| Vitória, Brazil | |
| Contact: Derval Pimentel | |
| Contact: Leandro De Assis Barbosa | |
| France | |
| Hospices Civils de Lyon | Not yet recruiting |
| Lyon, France | |
| Contact: Omer Eker | |
| Bicêtre Hospital | Recruiting |
| Paris, France | |
| Contact: Laurent Spelle | |
| Germany | |
| University Hospital Bonn (UKB Universitätsklinikum Bonn) | Not yet recruiting |
| Bonn, Germany, 53127 | |
| Contact: Felix Bode | |
| Universitätsklinikum Schleswig-Holstein Lübeck | Not yet recruiting |
| Lübeck, Germany, 23562 | |
| Contact: Schramm | |
| Contact: Royl | |
| Klinikum rechts der Isar der TU München | Recruiting |
| Munich, Germany | |
| Contact: Tobias Boeckh-Behrens | |
| Netherlands | |
| St. Antonius Ziekenhuis | Recruiting |
| Nieuwegein, Netherlands | |
| Contact: Jan Albert Vos | |
| Contact: Wouter Schonewille | |
| Spain | |
| Hospital Clinico San Carlos | Not yet recruiting |
| Madrid, Moncloa - Aravaca, Spain, 28040 | |
| Contact: Gomez Escalonilla | |
| Contact: Moreu | |
| Vall d'Hebron University Hospital | Recruiting |
| Barcelona, Spain | |
| Contact: Marc Ribo | |
| Hospital Virgen del Rocio | Recruiting |
| Sevilla, Spain | |
| Contact: Alejandro Gonzalez | |
| Contact: Francisco Moniche | |
| Turkey | |
| İstanbul Aydin University medical park florya hospital | Recruiting |
| Istanbul, Turkey | |
| Contact: Serdar Geyik | |
Sponsors and Collaborators
Philips Clinical & Medical Affairs Global
Investigators
| Principal Investigator: | Raul G Nogueira | UPMC Stroke Institute, Pittsburgh | |
| Principal Investigator: | Marc Ribo | Vall d'Hebron University Hospital, Barcelona |
Additional Information:
| Responsible Party: | Philips Clinical & Medical Affairs Global |
| ClinicalTrials.gov Identifier: | NCT04701684 |
| Other Study ID Numbers: |
XCY607-130512 |
| First Posted: | January 8, 2021 Key Record Dates |
| Last Update Posted: | January 29, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Additional relevant MeSH terms:
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Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |