A multicenter, randomized, controlled study to investigate EXtending the time for Thrombolysis in Emergency Neurological Deficits with Intra-Arterial therapy (EXTEND-IA).

Thrombolysis with tissue plasminogen activator is proven to reduce disability when given within 4·5 h of ischemic stroke onset. However, tissue plasminogen activator only succeeds in recanalizing large vessel arterial occlusion in a minority of patients. We hypothesized that anterior circulation ischemic stroke patients, selected with 'dual target' vessel occlusion and evidence of salvageable brain using computed tomography or magnetic resonance imaging 'mismatch' within 4·5 h of onset, would have improved reperfusion and early neurological improvement when treated with intra-arterial clot retrieval after intravenous tissue plasminogen activator compared with intravenous tissue plasminogen activator alone. EXTEND-IA is an investigator-initiated, phase II, multicenter prospective, randomized, open-label, blinded-endpoint study. Ischemic stroke patients receiving standard 0·9 mg/kg intravenous tissue plasminogen activator within 4·5 h of stroke onset who have good prestroke functional status (modified Rankin Scale <2, no upper age limit) will undergo multimodal computed tomography or magnetic resonance imaging. Patients who also meet dual target imaging criteria: vessel occlusion (internal carotid or middle cerebral artery) and mismatch (perfusion lesion : ischemic core mismatch ratio >1·2, absolute mismatch >10 ml, ischemic core volume <70 ml) will be randomized to either clot retrieval with the Solitaire FR device after full dose intravenous tissue plasminogen activator, or tissue plasminogen activator alone. The coprimary outcome measure will be reperfusion at 24 h and favorable clinical response (reduction in National Institutes of Health Stroke Scale by ≥8 points or reaching 0-1) at day 3. Secondary outcomes include modified Rankin Scale at day 90, death, and symptomatic intracranial hemorrhage.

Campbell BC ，Mitchell PJ ，Yan B ，Parsons MW ，Christensen S ，Churilov L ，Dowling RJ ，Dewey H ，Brooks M ，Miteff F ，Levi C ，Krause M ，Harrington TJ ，Faulder KC ，Steinfort BS ，Kleinig T ，Scroop R ，Chryssidis S ，Barber A ，Hope A ，Moriarty M ，McGuinness B ，Wong AA ，Coulthard A ，Wijeratne T ，Lee A ，Jannes J ，Leyden J ，Phan TG ，Chong W ，Holt ME ，Chandra RV ，Bladin CF ，Badve M ，Rice H ，de Villiers L ，Ma H ，Desmond PM ，Donnan GA ，Davis SM ，EXTEND-IA investigators ... -  《-》

A multicentre, randomized, double-blinded, placebo-controlled Phase III study to investigate EXtending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND).

Ma H ，Parsons MW ，Christensen S ，Campbell BC ，Churilov L ，Connelly A ，Yan B ，Bladin C ，Phan T ，Barber AP ，Read S ，Hankey GJ ，Markus R ，Wijeratne T ，Grimley R ，Mahant N ，Kleinig T ，Sturm J ，Lee A ，Blacker D ，Gerraty R ，Krause M ，Desmond PM ，McBride SJ ，Carey L ，Howells DW ，Hsu CY ，Davis SM ，Donnan GA ，EXTEND investigators ... -  《-》

Tenecteplase versus alteplase before endovascular thrombectomy (EXTEND-IA TNK): A multicenter, randomized, controlled study.

Campbell BC ，Mitchell PJ ，Churilov L ，Yassi N ，Kleinig TJ ，Yan B ，Dowling RJ ，Bush SJ ，Dewey HM ，Thijs V ，Simpson M ，Brooks M ，Asadi H ，Wu TY ，Shah DG ，Wijeratne T ，Ang T ，Miteff F ，Levi C ，Krause M ，Harrington TJ ，Faulder KC ，Steinfort BS ，Bailey P ，Rice H ，de Villiers L ，Scroop R ，Collecutt W ，Wong AA ，Coulthard A ，Barber PA ，McGuinness B ，Field D ，Ma H ，Chong W ，Chandra RV ，Bladin CF ，Brown H ，Redmond K ，Leggett D ，Cloud G ，Madan A ，Mahant N ，O'Brien B ，Worthington J ，Parker G ，Desmond PM ，Parsons MW ，Donnan GA ，Davis SM ，EXTEND-IA TNK Investigators ... -  《-》

Solitaire™ with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) trial: protocol for a randomized, controlled, multicenter study comparing the Solitaire revascularization device with IV tPA with IV t

Early reperfusion in patients experiencing acute ischemic stroke is critical, especially for patients with large vessel occlusion who have poor prognosis without revascularization. Solitaire™ stent retriever devices have been shown to immediately restore vascular perfusion safely, rapidly, and effectively in acute ischemic stroke patients with large vessel occlusions. The aim of the study was to demonstrate that, among patients with large vessel, anterior circulation occlusion who have received intravenous tissue plasminogen activator, treatment with Solitaire revascularization devices reduces degree of disability 3 months post stroke. The study is a global multicenter, two-arm, prospective, randomized, open, blinded end-point trial comparing functional outcomes in acute ischemic stroke patients who are treated with either intravenous tissue plasminogen activator alone or intravenous tissue plasminogen activator in combination with the Solitaire device. Up to 833 patients will be enrolled. Patients who have received intravenous tissue plasminogen activator are randomized to either continue with intravenous tissue plasminogen activator alone or additionally proceed to neurothrombectomy using the Solitaire device within six-hours of symptom onset. The primary end-point is 90-day global disability, assessed with the modified Rankin Scale (mRS). Secondary outcomes include mortality at 90 days, functional independence (mRS ≤ 2) at 90 days, change in National Institutes of Health Stroke Scale at 27 h, reperfusion at 27 h, and thrombolysis in cerebral infarction 2b/3 flow at the end of the procedure. Statistical analysis will be conducted using simultaneous success criteria on the overall distribution of modified Rankin Scale (Rankin shift) and proportions of subjects achieving functional independence (mRS 0-2).

Saver JL ，Goyal M ，Bonafe A ，Diener HC ，Levy EI ，Pereira VM ，Albers GW ，Cognard C ，Cohen DJ ，Hacke W ，Jansen O ，Jovin TG ，Mattle HP ，Nogueira RG ，Siddiqui AH ，Yavagal DR ，Devlin TG ，Lopes DK ，Reddy V ，du Mesnil de Rochemont R ，Jahan R ，SWIFT PRIME Investigators ... -  《-》

Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke.

Higashida RT ，Furlan AJ ，Roberts H ，Tomsick T ，Connors B ，Barr J ，Dillon W ，Warach S ，Broderick J ，Tilley B ，Sacks D ，Technology Assessment Committee of the American Society of Interventional and Therapeutic Neuroradiology ，Technology Assessment Committee of the Society of Interventional Radiology ... -  《-》