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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| direct transfer to angiography suite | Experimental | 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. Digital subtraction angiography (DSA) will be performed, and endovascular treatment (EVT) will be provided for patients with confirmed LVO. |
|
| conventional CT/MRI triage strategy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| direct transfer to angiography suite | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Randomization-to-imaging time | Immediately after the procedure | |
| Door-to-recanalization time | Immediately after the procedure | |
| Rates of intravenous thrombolysis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunyun Xiong | Contact | 86-10-59978350 | xiongyunyun@bjtth.org |
| Name | Affiliation | Role |
|---|---|---|
| Yunyun Xiong | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing tiantan hospital | Beijing | Beijing Municipality | 100070 | China |
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|
| conventional CT/MRI triage strategy | Procedure | 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. |
|
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. |
| 90 days |
| 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. | 90 days |
| The proportion of successful recanalization | The proportion of successful recanalization (expanded Thrombolysis in Cerebral Infarction [eTICI] 2b50-3) following endovascular treatment | Immediately after the procedure |
| The rate of early neurological improvement at 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. | 24 hours |
| 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 | 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. | Immediately after the procedure |
| The proportion of serious adverse events (SAEs) | The proportion of SAEs within 90 days | 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 | In-hospital mortality among participants with a final confirmed diagnosis of non-LVO, assessed from enrollment to hospital discharge. | From start of enrollment until hospital discharge (e.g. up to 7 days) |
| Length of hospital stay in non-LVO patients | 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. | From start of enrollment until hospital discharge (e.g. up to 7 days) |
| Proportion by discharge destination (non-LVO) | 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. | Immediately at hospital discharge |
| immediately after the 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. | 24 hours |
| Change in NIHSS score from baseline to 5-7 days after randomization or hospital discharge | Change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline, assessed at hospital discharge or 5-7 days after randomization, whichever occurs first. Scores on the NIHSS range from 0 to 42, with higher scores indicating a greater deficit. | Up to 5-7 days after randomization or hospital discharge, whichever occurs first |
| The modified Rankin Scale (mRS) score 0-3 at 90 days | The proportion of patients with an mRS score of 0-3 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. | 90 days |
| The modified Rankin Scale (mRS) score 5-6 at 90 days | The proportion of patients with an mRS score of 5-6 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. | 90 days |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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