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

Catalan Institute of Health

Status: Terminated

Conditions: Stroke, Acute

Treatments: Other: Direct Transfer to Angio Suite

Study type: Interventional

Funder types: Other

Identifiers

NCT04001738

PR(AG)156/2018

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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174 participants in 2 patient groups

Direct Transfer to Angio Suite

Active Comparator group

Description:

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.

Treatment:

Other: Direct Transfer to Angio Suite

Direct Transfer to CT Scan

No Intervention group

Description:

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.