Cerebrovascular accident (CVA) stroke
Conditions
Interventions
In this investigation the Direct-To-Angio-Suite triage workflow will be studied
in comparison with the currently conventional triage workflow involving the
CT/MR suite. The patients randomized to th
Sponsors
Philips
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is 18 years of age or older, or of legal age to give informed consent per state or national law 2. Baseline NIHSS score obtained prior to randomization must be equal or higher than 10 points 3. Subjects with no significant pre-stroke functional disability (modified Rankin scale 0 - 2) 4. Subjects suspected of acute ischemic stroke with an estimated arrival time at a stroke center (clinical investigational site participating in this study)
Exclusion criteria
Exclusion criteria: Clinical exclusion criteria: 1. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0. 2. Known Baseline platelet count 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) [1], the patient can be enrolled. 5. 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). 6. 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). 7. Patients with extreme vomiting. 8. Patients that are extremely agitated. 9. Seizures at stroke onset which would preclude obtaining a baseline NIHSS. 10. Serious, advanced, or terminal illness with anticipated life expectancy of less than one year. 11. Patients acquired stroke while in-hospital. 12. History of life threatening allergy (more than rash) to contrast medium. 13. Cerebral vasculitis. 14. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary endpoints: • Median time measurements (and interquartile range) in each study arm for the door-to-arterial puncture time: Time patient arrives at the CSC door to the time the skin of the patient is touched to perform first arterial puncture. • Median time measurements (and interquartile range) in each study arm for the door-to-reperfusion time: Time patient arrives at the CSC door to the time of successful vessel recanalization (eTICI >= 2b). • 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 Safety endpoints: • Report all adverse events, including: o Mortality and Stroke related mortality at 90 days. o Symptomatic ICH rates at 24 (-12/+24) hours after randomization. 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: 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. o Asymptomatic ICH rates at 24 (-12/+24) hours after randomization. All intracerebral hemorrhages will be classified by the blinded Core Lab using the Heidelberg Bleeding Classification. All the intracerebral hemorrhages which are not symptomatic, are classified as asymptomatic. o Adverse events of special interest are Emboli to Uninvolved territory, Vessel perforation and Vessel dissection. T | — |
Countries
Netherlands
Outcome results
None listed