About this trial
The investigators initiated a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled trial to evaluate the efficacy and safety of the direct transfer to angiography suite (DTAS) triage strategy compared to the conventional triage strategy with CT/MRI in patients with suspected large artery occlusive (LVO) within 6 hours of symptom onset.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥18 years old;
Patients presenting with symptoms or signs suggestive of acute large vessel occlusion (LVO) stroke;
Randomization within 6 hours of symptom onset;
Baseline NIHSS score ≥10 points prior to randomization;
Disqualifiers
Refusal of endovascular treatment;
Allergy to contrast agents;
Clinical symptoms or signs suggestive of intracranial hemorrhage (e.g., severe headache, seizures, or signs of increased intracranial pressure);
Transferred patients (e.g., from centers without thrombectomy capability);
Trial design
Parallel
Treatments tested in this trial
direct transfer to angiography suite
Procedure/SurgeryPatients will bypass the emergency radiology imaging step and be directly transferred to the angiography suite. After screening for intracranial hemorrhage using flat-panel CT, intravenous tenecteplase will be administered according to current guidelines. DSA will be performed, and EVT will be provided for patients with confirmed LVO. EVT includes thrombectomy with stent retrievers, thromboaspiration, intra-arterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discretion of the interventional team.
conventional CT/MRI triage strategy
Procedure/SurgeryPatients will undergo routine imaging, including non-contrast CT/CTA/CTP or MRI/MRA/PWI. For ischemic stroke patients, intravenous tenecteplase will be administered according to current guidelines. Patients with imaging-confirmed LVO will proceed to the angiography suite for further EVT following the standard procedure. EVT includes thrombectomy with stent retrievers, thromboaspiration, intra-arterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discretion of the interventional team.
Treatment groups
Trial outcomes
Primary outcomes
The modified Rankin Scale (mRS) score 0-2 at 90 days
The proportion of patients with an mRS score of 0-2 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.
Secondary outcomes
Rates of endovascular treatment
Door-to-puncture time
Ordinal distribution of modified Rankin Scale (mRS) at 90 days
Ordinal distribution of mRS at 90 days (shift analysis). The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.
The modified Rankin Scale (mRS) score of 0-1 at 90 days
The proportion of patients with an mRS score of 0-1 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.
Other outcomes
Randomization-to-imaging time
Door-to-recanalization time
Rates of intravenous thrombolysis
Change in NIHSS score from baseline to 24 hours after randomization
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating a greater deficit.
Sponsors and contacts
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