Ischemic Stroke, Large Vessel Occlusion
Conditions
Keywords
ischemic stroke, large vessel occlusion, endovascular treatment, direct transfer to angiography suite
Brief summary
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.
Interventions
PROCEDUREdirect transfer to angiography suite
Patients 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.
PROCEDUREconventional CT/MRI triage strategy
Patients 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.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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; * Pre-stroke modified Rankin Scale (mRS) score ≤2; * Written informed consent from patients or their legally authorized representatives.
Exclusion criteria
* 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); * Seizure at stroke onset, postictal paralysis, or inability or unwillingness to cooperate due to epilepsy or other neurological or psychiatric disorders; * Clinically unstable conditions requiring urgent life-support treatment; * Other standard contraindications to endovascular treatment; * Any terminal illness such that the patient would not be expected to survive more than 1 year; * Pregnant women, nursing mothers, or women with a positive pregnancy test at admission; * Unlikely to adhere to the trial protocol or follow-up; * Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study; * Participation in other interventional clinical trials within the previous 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The modified Rankin Scale (mRS) score 0-2 at 90 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Rates of endovascular treatment | Immediately after the procedure | — |
| Door-to-puncture time | Immediately after the procedure | — |
| Ordinal distribution of modified Rankin Scale (mRS) at 90 days | 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 | 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. |
| The proportion of successful recanalization | Immediately after the procedure | The proportion of successful recanalization (expanded Thrombolysis in Cerebral Infarction \[eTICI\] 2b50-3) following endovascular treatment |
| The rate of early neurological improvement at 24 hours | 24 hours | The rate of early neurological improvement at 24 hours after randomization, defined as a National Institute of Health Stroke Scale (NIHSS) score ≤2 or a reduction of ≥8 points from baseline. Scores on the NIHSS range from 0 to 42, with higher scores indicating a greater deficit. |
| Symptomatic intracranial hemorrhage within 36 hours (as defined by SITS-MOST definition) | 36 hours | — |
| The proportion of all-cause mortality at 90 days | 90 days | — |
| The proportion of stroke-related mortality at 90 days | 90 days | — |
| The proportion of procedural complications | Immediately after the procedure | Vessel perforation, arterial dissection, access site complication requiring surgical repair or blood transfusion, intraprocedural mortality, and other procedure-related complications determined by the Data and Safety Monitoring Board. |
| The proportion of serious adverse events (SAEs) | 90 days | The proportion of SAEs within 90 days |
| Time to alternative treatment initiation in non-LVO patients | Immediately after the intervention | — |
| Rates of misclassification as intracranial hemorrhage (ICH), distal vessel occlusion, or stroke mimics in non-LVO patients | Immediately after the intervention | — |
| Time to initiation of antihypertensive therapy, when indicated, in ICH patients | Immediately after the intervention | — |
| Time to achievement of target blood pressure in ICH patients | Immediately after the intervention | — |
| In-hospital mortality in non-LVO patients | From start of enrollment until hospital discharge (e.g. up to 7 days) | In-hospital mortality among participants with a final confirmed diagnosis of non-LVO, assessed from enrollment to hospital discharge. |
| Length of hospital stay in non-LVO patients | From start of enrollment until hospital discharge (e.g. up to 7 days) | Length of hospital stay among patients with a final confirmed diagnosis of non-LVO, defined as the number of days from enrollment to hospital discharge. |
| Proportion by discharge destination (non-LVO) | Immediately at hospital discharge | Assessed at hospital discharge among patients with a final confirmed diagnosis of non-LVO. Discharge destination will be reported as proportions: home, transfer to another hospital, or rehabilitation center. |
Countries
China
Contacts
CONTACTYunyun Xiong
PRINCIPAL_INVESTIGATORYunyun Xiong
Beijing Tiantan Hospital
Outcome results
None listed