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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct tot Angiography Suite (DTAS) triage workflow | Experimental |
| |
| Conventional CT/MR triage workflow | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct to Angio Suite (DTAS) Philips' CBCT triage | Device | Stroke patients are diagnosed and treated (mechanical thrombectomy) in the same angio suite |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up | The difference in the distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up in the Target population to determine the performance of the DTAS triage imaging workflow involving Stroke CBCT reconstructions by the investigational device or SmartCT R3 in comparison to the conventional CT/MR triage imaging workflow. The 90 day mRS score will be evaluated by a blinded assessor of a pool of blinded assessors (i.e., a specialist with mRS certification) at the local hospital by performing a structured interview of the patient in person using the Rankin Focused Assessment (RFA) structured mRS questionnaire. If the subject is unable to return to the clinic for the day 90 ± 14 visit, a (video) call in which the mRS score is assessed by a blinded assessor is preferable to no assessment. | 90 ± 14 days follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Peri-procedural time |
| Median time measurements (door-to-reperfusion time) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Adverse events (mortality at 90 days) | Mortality and stroke-related mortality | 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. |
Inclusion Criteria:
Exclusion Criteria:
Clinical exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerrits | Contact | +31 6 55 48 29 31 | carin.gerrits@philips.com | |
| Eshuis | Contact | +31 6 28 73 92 80 | peter.g.eshuis@philips.com |
| Name | Affiliation | Role |
|---|---|---|
| Raul G Nogueira | UPMC Stroke Institute, Pittsburgh | Principal Investigator |
| Marc Ribo | Vall d'Hebron University Hospital, Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Medical Center | Recruiting | Jacksonville | Florida | 32207 | United States |
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| Label | URL |
|---|---|
| WE-TRUST study information website | View source |
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| Conventional CT/MR triage | Procedure | First a CT or MRI exam is acquired for triage. In case of an ischemic stroke the patient is then treated in an interventional suite. |
|
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 | 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 |
| 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. | 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. | 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. | 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. | 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 | 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) | 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) | 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 | 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. | 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 | 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 | 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). | 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) | 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 | 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. | 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 | 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). | 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). | 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. | 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) | 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. | 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 | 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). | 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). | 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). | At 90 ± 14 days post-procedure |
| Exploratory: Infarct volume (other clinical outcome) | Infarct volume evaluated on CT or MRI | 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 | 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 | 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). | On day 1 |
| Grady Memorial Hospital/Emory University | Not yet recruiting | Atlanta | Georgia | 30303 | United States |
|
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10467 | United States |
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| La Sagrada Familia Clinic | Recruiting | José Hernández | Argentina |
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| UZ Brussels | Recruiting | Brussels | Belgium |
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| Hospital Geral de Fortaleza | Recruiting | Fortaleza | Brazil |
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| Hospital de Base | Not yet recruiting | São José do Rio Preto | Brazil |
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| Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba | Recruiting | Vitória | Brazil |
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| Hospices Civils de Lyon | Completed | Lyon | France |
| CHU Montpellier | Recruiting | Montpellier | France |
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| Bicêtre Hospital | Recruiting | Paris | France |
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| University Hospital Bonn (UKB Universitätsklinikum Bonn) | Recruiting | Bonn | 53127 | Germany |
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| Klinikum Kassel | Recruiting | Kassel | Germany |
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| Universitätsklinikum Schleswig-Holstein Lübeck | Recruiting | Lübeck | 23562 | Germany |
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| Klinikum rechts der Isar der TU München | Recruiting | Munich | Germany |
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| St. Antonius Ziekenhuis | Completed | Nieuwegein | Netherlands |
| Haaglanden Medical Center | Withdrawn | The Hague | Netherlands |
| University Emergency Hospital Bucharest | Not yet recruiting | Bucharest | Romania |
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| Hospital Clinico San Carlos | Recruiting | Madrid | Moncloa - Aravaca | 28040 | Spain |
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| Vall d'Hebron University Hospital | Recruiting | Barcelona | Spain |
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| Hospital Universitari Doctor Josep Trueta de Girona | Recruiting | Girona | Spain |
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| Hospital Virgen del Rocio | Recruiting | Seville | Spain |
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| İstanbul Aydin University medical park florya hospital | Completed | Istanbul | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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