Evaluation of Direct Transfer to Angiography Suite vs. Computed Tomography Suite in Endovascular Treatment: Randomized Clinical Trial (ANGIOCAT)

Study Overview
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Brief Summary
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To evaluate the hypothesis that an ultra-fast triage with one-stop in angiography suite based on cone-beam CT compared to traditional protocol offers a better outcome in the distribution of the modified Rankin Scale scores at 90 days in acute ischemic stroke patients with suspected large vessel occlusion (LVO) within 6 hours from symptoms onset.

Detailed Description
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Prospective, randomized, open, treatment-blinded trial of acute stroke patients with suspected large vessel occlusion within 6 hours from symptoms onset in which two strategies will be compared: Direct Transfer to Angiography Suite (DTAS) vs. Computed Tomography Suite (DTCT). The study will be unicentric however there is the possibility of incorporating new stroke centers with previous experience of at least 50 DTAS cases. The RACE scale (Rapid Arterial oCclusion Evaluation) will be used as a prehospital screening tool to identify acute stroke patients with suspicion of LVO. Once prenotifying the imminent arrival and the verified inclusion and exclusion criteria by the Neurologist at arrival, the patient will be randomized by an app in one of both study protocols. Subjects will be followed up to 90 days post-randomization.

Official Title
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Evaluation of Direct Transfer to Angiography Suite vs. Computed Tomography Suite in Endovascular Treatment: Randomized Clinical Trial

Conditions
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Stroke, Acute

Intervention / Treatment
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* Other: Direct Transfer to Angio Suite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Large vessel occlusion suspected acute stroke codes (RACE>4) within 6 hours from stroke onset which are prenotified from emergency medical system. Confirmed NIHSS>10 at arrival. Good pre-stroke functional status (mRS≤2) Angiography suite available. Endovascular treatment team available (Neurologist, Interventionist, anesthesiologist, Nursery, Technicians…) Exclusion Criteria: Hemodynamically unstable patients who requires of advanced vital support. Patients with an advanced disease that conditions a life expectancy lower than 6 months. Participation in other clinical trial with a drug or device which could influence in the outcome. Patients with neurological or psychiatric disease that could confound future evaluations. Lack of disponibility for 90 days tracing.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct Transfer to Angio Suite<br>After a fast neurological evaluation, patient will be direct transferred to angiography suite where endovascular treatment (EVT) team will be waiting for it. It will be done a cone beam-CT and if the image don't contraindicate endovascular treatment it will be performed and the large vessel occlusion will be confirmed by arteriography. If intravenous treatment have not been previously administered, it will be able to start in parallel. | Other: Direct Transfer to Angio Suite<br>* Patient will be direct transferred to angiography suite where EVT team will be waiting for it.<br>|
| No Intervention: Direct Transfer to CT Scan<br>After a fast neurological evaluation, patient will be transferred to CT suite where usual image protocol will be performed (CT and CT-angio). Within 6 hours from onset CT perfusion could be required to take detections. Once interpreted image results, it will be decided intravenous and/or endovascular treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome measurde by modified Rankin Scale score (shift analysis) | Modified Rankin Scale score in ischemic stroke patients with large vessel occlusion as evaluated through a structured telephone-based interview performed by a central assessor who is blinded to group assignment. Modified Rankin Scale measures functional status with a range from 0 (asymptomatic) to 6 (dead). | 90 days | 
| Rate of patients with treatment associated complications. | Lack of treatment associated complications, mainly hemorrhagic transformation. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay of inhospital times | Time from door to groin puncture | 8 hours | 
| Rate of dramatic improvement | 10 NIHSS points drop or NIHSS <2 | 24 hours | 
| Rate of good functional outcome | Modified Rankin Scale score ≤2 | 90 days | 
| Rate of patients treated by endovascular treatment |  | 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endovascular treatment, Large Vessel Occlusion