[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Santiago Ortega Gutierrez\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100579561","delay-avoiding-primary-evaluation-for-thrombectomy-of-acute-stroke-patients-with-large-vessel-occlusion-in-the-angiography-suite-100579561",false,"NCT06825897","Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe","Delay Avoiding Primary Evaluation for Thrombectomy for Acute Stroke Patients With Large Vessel Occlusion in the Angiography Suite (DIRECT) Trial","DIRECT","Inclusion Criteria:\n\nTo be eligible for participation in the DIRECT trial, an individual must meet all of the following criteria:\n\n1. Age: ≥ 18 years of age.\n2. Clinical Presentation: Present to a participating TSC with signs or symptoms suggestive of acute LVO stroke.\n3. Stroke Severity: Baseline NIHSS of 10 or higher.\n4. Time since LKW: Time from LKW to arrival at the TSC must be within 7 hours.\n\nAdditional criteria\n\nFor all Interfacility Transfers:\n\n1\\. If imaging was performed at the outside facility, the time from the first imaging to arrival at the thrombectomy center must exceed 90 minutes.\n\nFor all the Conventional Triage Arm, participants must also meet the following criteria:\n\n1. Presence of a qualifying LVO by CTA or MRA imaging; or\n2. For Large Core Patients: Patients with large core infarcts (CT-ASPECT score ≤ 5, DWI-ASPECT score ≤ 5, or infarct volume ≥ 70 cc) will be enrolled, irrespective of treatment decisions regarding embolectomy.\n\nFor all DTAS Arm:\n\n1\\. Patients who do not have LVO occlusions in the angiography suite assessment (ICH, distal occlusions or mimics) will be enrolled, irrespective of treatment decisions regarding embolectomy.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in the trial:\n\n1. Time Restrictions: Presentation to a thrombectomy-capable center more than 7 hours from LSW.\n2. Imaging Criteria for Interfacility Transfer Patients: At sites enrolling transfer patients, any patient arriving from an outside hospital with time from imaging study at the presenting hospital to arrival at the TSC not exceeding 90 minutes.\n3. Hemorrhagic Stroke: Presence of intracranial hemorrhage on brain imaging in the conventional strategy as Heidelberg that renders thrombectomy contraindicated.","ALL","18 Years",{"count":20,"type":21},2039,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to compare two strategies for treating adults with suspected large vessel occlusion stroke within 7 hours of symptom onset. Researchers will evaluate whether direct transfer to the neurointerventional angiography suite improves recovery and reduces disability compared to the conventional approach of first being evaluated in the emergency department. The study will also assess safety and other health outcomes to guide care for stroke patients.",[27],"Stroke, Acute",[29,30,31],"Large Vessel Occlusion","Acute Ischemic Stroke","Pragmatic Clinical Trial","RECRUITING","2026-03-11",{"date":35,"type":36},"2026-03-13","ACTUAL",{"date":38,"type":36},"2026-01-27",{"date":40,"type":21},"2028-04-30",{"name":42,"class":43},"Santiago Ortega Gutierrez","OTHER",6,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":67,"locationsCount":5},"100593085","endovascular-therapy-for-late-window-ischemic-stroke-patients-selected-by-automatic-plain-computerized-tomography-100593085","NCT07001852","EnDOvascular Therapy for Late WiNdow IschEmic Stroke Patients Selected bY AutoMatic Plain ComputErized Tomography","DONE SYMPLE","Inclusion Criteria:\n\n1. 18 to 80 years of age:\n\n   1. Pre-stroke score (mRS) of 0-1 in participants aged 18 to 70 years.\n   2. Pre-stroke Modified Rankin Scale (mRS) score of 0 in participants older than 70 years.\n2. Presenting with signs and symptoms consistent with an acute ischemic stroke within 24-72 hours from last known well. \\*\n3. Baseline NIHSS ≥8.\n4. NCCT imaging indicating the existence of an anterior circulation LVO by an automated software, or CTA (when available).\n5. Core volume ≤ 70 cc determined by a deep learning algorithm in automated software and\u002For ASPECTS scoring ≥ 6. \\*\\*\n6. Arterial puncture within 72 hours (after the first symptoms or LKW).\n7. Arterial puncture within 90 minutes from initial CT.\n8. Ability to randomize within 72 hours after stroke onset (last seen well).\n9. Ability to obtain signed informed consent or subject's Legally Authorized representative (LAR) has signed Consent form \\*\\*\\*\n\n   * Patients in the 6-24-hour after Last Known Well (LKW) may be enrolled only in centers where thrombectomy is not offered as standard of care due to the absence of advanced imaging capabilities.\n\n     * In cases of discrepancy between the automated tool LVO detection and volume, and ASPECT Score or CTA judgment or Computed Tomography Angiography CTA findings, ASPECTS and CTA will take precedence.\n\n       * If approved by local ethics committee and country regulations, the investigator is allowed to enroll a patient utilizing emergency informed consent procedures if neither the patient nor the representative or person of trust is available to sign the informed consent form. However, as soon as possible, the patient is informed, and his\u002Fher consent is requested for the possible continuation of this research.\n\nExclusion Criteria:\n\n1. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test.\n2. Known severe allergy (more than a rash) to contrast media uncontrolled by medications.\n3. Refractory hypertension (defined as persistent systolic blood pressure \\>185 mmHg or diastolic blood pressure \\>110 mmHg) despite medication.\n4. CT evidence of the following conditions:\n\n   * Midline shift or herniation.\n   * Evidence of intracranial hemorrhage.\n   * Mass effect with effacement of the ventricles.\n5. Bilateral strokes.\n6. Clot retrieval previously attempted \\\u003C6 hours.\n7. Treated with thrombolytics \\>4.5 hours after last seen well.\n8. Intracranial tumors.\n9. Life expectancy less than 90 days prior to stroke onset.\n10. Participation in another randomized clinical trial that could confound the evaluation of the study.\n11. Presumed septic embolus, or suspicion of bacterial endocarditis.\n12. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept).\n13. Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed.","80 Years",{"count":54,"type":21},500,[24],"The DONE SYMPLE Investigator-initiated phase III prospective, randomized, open-label, blinded endpoint-controlled clinical trial.\n\nThis clinical trial is a global clinical study testing whether a procedure called endovascular therapy, which removes blood clots from blocked brain arteries, can safely benefit more stroke patients when used up to 72 hours after symptoms begin. Endovacular Therapy is already proven to improve recovery in patients treated within 6 hours, but only when advanced imaging like Computed Tomography (CT) perfusion or Magnetic Resonance Imaging (MRI) is available to guide treatment. Unfortunately, many hospitals, specially in underserved areas, do not have access to this type of imaging.\n\nThis trial will investigate whether a basic brain scan called non-contrast CT, which is widely available in hospitals around the world, can be used instead. Special software will automatically analyze the CT scan to help doctors decide if a patient has enough brain tissue left to save with Endovascular Therapy. If this simpler approach works, it could expand access to lifesaving stroke care for more people globally.\n\nThe study will enroll 500 adult stroke patients, ages 18 to 80, with a large vessel blockage in the brain's anterior circulation, moderate to severe stroke symptoms, and who are between 6 and 72 hours from when they were last known to be well. All participants will undergo CT imaging analyzed by the automated software. If the scan shows a small core of already damaged brain tissue and a larger area of threatened but still viable brain, the patient will qualify.\n\nParticipants will be randomly assigned to receive either standard medical therapy alone or medical therapy plus Endovasculat Therapy which involves inserting a catheter through a blood vessel to reach the brain and using a device to remove the clot. This procedure is performed by trained stroke or neurointerventional specialists. The study is \"open-label,\" meaning patients and doctors know which treatment is given, but the assessment of patient recovery will be done by independent reviewers who do not know the group assignments.\n\nThe primary goal is to determine if patients who receive Endovascular Therapy have better recovery at 90 days, measured by a scale called the modified Rankin Scale, which assesses how much disability a patient has after a stroke. The trial will also look at safety (especially brain bleeding after treatment), size and growth of brain injury on follow-up scans, recovery of strength and language, and overall quality of life and survival. Imaging will be reviewed centrally by a specialized team, and results will be analyzed to see how well Endovascular Therapy performs using this new patient selection method.\n\nThe DONE SYMPLE Trial is sponsored by Foundacio Ictus in Barcelona Spain and the University of Iowa is the Central Coordinating Center for the Study. It will take place at up to 20 hospitals worldwide. All patients will be followed closely with exams and imaging at specific time points up to 90 days after treatment.\n\nIf successful, this trial could change stroke care around the world by proving that Endovascular Therapy can be used safely and effectively even without advanced imaging, using tools available in most hospitals. This could help more stroke patients, especially in rural or resource-limited areas, access treatments that may improve their chances of recovery and reduce long-term disability.",[58],"Stroke Acute",[60,30],"large vessel occlusion","2025-10-14",{"date":63,"type":36},"2025-10-16",{"date":61,"type":36},{"date":66,"type":21},"2029-07-01",{"name":42,"class":43},""]