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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 perfusion-guided endovascular treatment (EVT) compared to standard medical care for patients with acute ischemic stroke due to medium vessel occlusion (MeVO) within 24 hours from symptom onset.
Adult acute ischemic stroke patients due to primary medium vessel occlusions (non-dominant proximal M2 or mid-distal M2/M3 segments of the middle cerebral artery, A1/A2/A3 segments of the anterior cerebral artery, and P1/P2/P3 segments of the posterior cerebral artery) confirmed by CTA/MRA and responsible for the signs and symptoms of acute ischemic stroke with baseline National Institutes of Health Stroke Scale (NIHSS) ≥8 will be enrolled in this trial. The investigators use perfusion imaging to select subjects and the enrolled patients have target mismatch profile on CTP or MRI+PWI (ischemic core volume <70mL, mismatch ratio>1.2, mismatch volume >10mL). The eligible patients will be randomly assigned to receive endovascular treatment (EVT) +best medical treatment or best medical treatment within 24 hours after the time that the patient was last known to be well (including after stroke on awakening and unwitnessed stroke). The primary outcome is the proportion of patients with an mRS score ≤ 1 at 90 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular treatment (EVT) +Best medical treatment | Experimental | The treating physician should attempt to perform EVT with the goal to restore blood flow to the affected vascular territory immediately after randomisation. EVT included thrombectomy with stent retrievers, thromboaspiration, intraarterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discretion of the interventional team. All decisions regarding the performance of EVT are made by the treating physician, based on his/her own judgement, and using local standards for endovascular treatment technique and devices and/or medications used for EVT. All other treatments (especially after-care and best medical treatment) will not differ between the intervention and control group. |
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| Best medical treatment (BMT) | Other | Administration of BMT should be done according to routine clinical practice and current guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular treatment | Procedure | EVT included thrombectomy with stent retrievers, thromboaspiration, intraarterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discretion of the interventional team. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients who have a score of 0 or 1 on the modified Rankin Scale (mRS) at 90 days | The proportion of patients with an mRS score ≤ 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days |
| The proportion of patients with an modified Rankin Scale (mRS) score of 0-2 at 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of successful recanalization | The proportion of successful recanalization(eTICI 2b50-3) following EVT | immediately after the intervention |
| The proportion of improvement on reperfusion at 24 hours after randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunyun Xiong, professor | Contact | 86-10-59978350 | xiongyunyun@bjtth.org |
| Name | Affiliation | Role |
|---|---|---|
| Yunyun Xiong, professor | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing tiantan hospital | Recruiting | Beijing | Beijing Municipality | 100070 | China |
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| Best medical treatment (BMT) | Drug | Administration of BMT should be done according to routine clinical practice and current international guidelines. Administration of BMT must not be delayed by randomisation and should be done independently from participation in this trial. |
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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 |
| 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 ≤1 or ≥4 points compared with the baseline) | 24 hours |
| The proportion of patients with an modified Rankin Scale (mRS) score of 5-6 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 |
| The median value of EuroQol 5-Dimension (EQ-5D) index | EuroQol 5-Dimension (EQ-5D) index at 90 days and 1 year. The EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D) is a standardized instrument for the measurement of health status. The domains mobility, self-care, everyday activity, pain or physical discomfort, and fear or depression are assessed on a five-point scale, with 1 indicating no problem in this domain and 3 indicating extreme problems. The visual analogue scale ranges from 0 to 100, with 0 indicating the worst health imaginable and 100 the best health imaginable. | 90 days and 1 year |
| Ordinal distribution of modified Rankin Scale (mRS) at 1 year | Ordinal distribution of modified Rankin Scale (mRS) 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. | 1 year |
| The proportion of symptomatic intracranial hemorrhage | Symptomatic intracranial hemorrhage within 24 hours (as defined by Heidelberg criteria) | 24 hours |
| The proportion of all-cause mortality | All-cause mortality at 90 days and 1 year | 90 days and 1 year |
| The proportion of systematic bleeding | Moderate or severe systemic bleeding is defined according to the criteria established in the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) trial | 90 days |
| The proportion of serious adverse events (SAEs) | serious adverse events within 90 days | 90 days |
Improvement on reperfusion is defined as >90% reduction in Tmax > 6s lesion volume
| 24 hours |
| The proportion of complete recanalization at 24 hours after randomization | Complete recanalization is defined as an Arterial Occlusion Lesion scale [AOL] score of 3 (scale range, 0 [no recanalization] to 3 [complete recanalization]). | 24 hours |
| Beijing Daxing District People's Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Xingtang County People's Hospital | Recruiting | Longzhou | Hebei | China |
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| Luoyang Yiluo Hospital | Recruiting | Luoyang | Henan | China |
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| People's Hospital of Queshan | Recruiting | Panlong | Henan | China |
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| Changle People's Hospital | Recruiting | Changle | Shandong | China |
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| 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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