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| Name | Class |
|---|---|
| Changhai Hospital | OTHER |
| The Affiliated Hospital Of Guizhou Medical University | OTHER |
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Exploring the Efficacy and Safety of Emergent Endovascular Treatment in Patients with Mild Ischemic Stroke Caused by Acute Anterior Circulation Large Vessel Occlusion based on Perfusion Imaging Screening
This study aims to select suitable patients with mild AIS caused by anterior circulation LVO with mismatch volume of the ischemic penumbra based on screen of cerebral perfusion imaging. It is a prospective, multicenter, endpoint-blinded, randomized controlled trial design, and aim to explore the efficacy and safety of EVT for mild AIS patients with anterior circulation large vessel occlusion within 24 hours of onset.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group:Endovascular treatment | Experimental | Interventionist choose the optimal EVT strategy and device based on the patient's condition and local guidelines. This may include, but not limited to, stent-retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation and so on. The EVT regimen and relevant time points will be accurately recorded. The patient will receive the best medical treatment according to the local guidelines. |
|
| Control group: Best medical treatment | Placebo Comparator | Patients will receive the best medical treatment according to local guidelines, including antiplatelet agents, anticoagulants, thrombolysis, etc., but not any EVT. In the control arm, rescue EVT is allowed in patients with disease progression leading to an increase in NIHSS≥4 and excluding the impact of non-stroke factors, and the onset-to-treatment time is within 24 hours.This may include, but not limited to, stent-retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation and so on. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental group:Intervention Group | Other | Intervention Group:Interventionist choose the optimal endovascular treatment (EVT) strategy and device based on the patient's condition and local guidelines. The patient will receive the best medical treatment according to the local guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of excellent outcome at () days | mRS score 0-1 | 90±7 days |
| Measure | Description | Time Frame |
|---|---|---|
| mRS shift | distribution of mRS scores | 90±7 days |
| proportion of subjects with good neurological function prognosis | mRS score 0-2 | 90±7 days |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of symptomatic intracranial hemorrhage | according to the Heidelberg criteria | within 48 hours |
| rate of early neurological deterioration | an increase in NIHSS≥4 or an increase of ≥2 in any individual item |
Inclusion Criteria
Clinical Exclusion Criteria
Imaging Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wenhuo Chen, MD | Fujian Medical University Union Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35599458 | Background | Sarraj A, Albers GW, Blasco J, Arenillas JF, Ribo M, Hassan AE, de la Ossa NP, Wu TY, Cardona Portela P, Abraham MG, Chen M, Maali L, Kleinig TJ, Cordato D, Wallace AN, Schaafsma JD, Sangha N, Gibson DP, Blackburn SL, De Lera Alfonso M, Pujara D, Shaker F, McCullough-Hicks ME, Moreno Negrete JL, Renu A, Beharry J, Cappelen-Smith C, Rodriguez-Esparragoza L, Olive-Gadea M, Requena M, Almaghrabi T, Mendes Pereira V, Sitton C, Martin-Schild S, Song S, Ma H, Churilov L, Mitchell PJ, Parsons MW, Furlan A, Grotta JC, Donnan GA, Davis SM, Campbell BCV; PERFECT-MILD Collaborators. Thrombectomy versus Medical Management in Mild Strokes due to Large Vessel Occlusion: Exploratory Analysis from the EXTEND-IA Trials and a Pooled International Cohort. Ann Neurol. 2022 Sep;92(3):364-378. doi: 10.1002/ana.26418. Epub 2022 Jul 25. | |
| 41974578 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 8, 2023 | Apr 25, 2026 |
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Intervention group: Endovascular treatment Control group:Best medical treatment
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Endpoint-blined
|
| Control group:best medical treatment | Other | Best medical treatment:Patients will receive the best medical treatment according to local guidelines, including antiplatelet agents, anticoagulants, thrombolysis, etc., but not any EVT. In the control arm, rescue EVT is allowed in patients with disease progression leading to an increase in NIHSS≥4 and excluding the impact of non-stroke factors, and the onset-to-treatment time is within 24 hours. |
|
| within 7 days |
| mortality | death | 90±7 days |
| Derived |
| Wu M, Yi T, Xing P, Wu YM, Lin DL, Lin X, Huang MZ, Ren Z, Liu J, Yang P, Zheng T, Zhang M, Wang H, Chen W. Endovascular treatment for MILD ischaemic stroke with acute anterior circulation large vessel occlusion: a multicentre, prospective, randomised, clinical trial (MILD-MT) protocol. Stroke Vasc Neurol. 2026 Apr 13:svn-2025-004832. doi: 10.1136/svn-2025-004832. Online ahead of print. |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2026 | Apr 26, 2026 | SAP_001.pdf |
| 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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