protocolSection identificationModule nctId: NCT06297863, orgStudyIdInfo id: DOWN-SUITE, briefTitle: Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke, acronym: DOWN-SUITE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University of Milano Bicocca, class: OTHER, collaborators name: Fondazione IRCCS San Gerardo dei Tintori, collaborators name: Azienda Ospedaliero-Universitaria Careggi, Firenze, collaborators name: Azienda Ospedaliera Universitaria Gaetano Martino, Messina, descriptionModule briefSummary: The DOWN-SUITE study is multicenter, randomised, controlled, open-label clinical trial with blinded outcome assessment comparing collateral status in patients with acute ischemic stroke treated with an in-hospital application of head down tilt -10° to -15° (HDT15) versus usual positioning (0° to +30°) before endovascular mechanical thrombectomy.This study will involve adult patients who are eligible for mechanical thrombectomy and who have acute ischemic stroke due to left or right middle cerebral artery occlusion (M1 segment).The investigators hypothesise that HDT15, applied in acute ischemic stroke patients with a large vessel occlusion, will improve collateral circulation, prolong the survival of the ischemic penumbra and improve the clinical benefit from mechanical thrombectomy compared with standard of care (usual positioning 0° to +30°)., conditionsModule conditions: Acute Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The DOWN-SUITE trial is a prospective, multicenter, proof of concept, randomised, controlled, open label, phase 2a/b clinical trial with blinded outcome assessment, comparing cerebral collateral status in patients with acute ischemic stroke due to middle cerebral artery occlusion (M1 segment) treated with in-hospital application of HDT15 (-10° to -15°) versus usual positioning (0° to +30°), before and during mechanical thrombectomy., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: A blinded central imaging core lab, whose members will be unaware of the procedure assignments, will assess all imaging outcomes, including the primary efficacy outcome (collateral status, assessed during the pretreatment diagnostic angiographic series of mechanical thrombectomy), whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 118, type: ESTIMATED, armsInterventionsModule interventions name: HEAD DOWN TILT -10° to -15°, outcomesModule primaryOutcomes measure: Good collateral status, secondaryOutcomes measure: Feasibility of HDT15, secondaryOutcomes measure: Delay to thrombectomy, secondaryOutcomes measure: Vomiting, secondaryOutcomes measure: Early neurological deterioration, secondaryOutcomes measure: Symptomatic intracranial hemorrhage, secondaryOutcomes measure: Aspiration pneumonia, secondaryOutcomes measure: Neurological disability, secondaryOutcomes measure: Systolic blood pressure, secondaryOutcomes measure: Diastolic blood pressure, secondaryOutcomes measure: Oxygen saturation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False