[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05911568":3,"trial-entities:NCT05911568":369,"trial-summary:NCT05911568":373},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":44,"sex":57,"minimum_age":58,"maximum_age":23,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":64,"locations":67,"central_contacts":350,"overall_officials":359,"references":367,"see_also_links":368},"NCT05911568","2023-0299","Treatment With Endovascular Intervention for STroke Patients With Existing Disability","RECRUITING","2028-04-15","2026-04","2026-04-15","2023-11-16","University of Cincinnati","OTHER",true,"TESTED will compare the risks and benefits of endovascular thrombectomy (EVT) to medical management (no EVT) in ischemic stroke patients who have a blockage in one of the large blood vessels in the brain and have a moderate-to-severe disability prior to their stroke.","People with disabilities can suffer acute ischemic stroke (AIS). Endovascular clot removal is a breakthrough therapy for large vessel occlusion (LVO) AIS. Pre-stroke disabled patients were excluded from pivotal EVT stroke trials, so whether EVT is effective for those with pre-stroke disability is not known. As a result, two competing, widely-practiced, treatment paradigms have emerged based on individual practitioners' extrapolation of EVT benefits and safety from patients without a pre-stroke disability to those with disability: 1) Multimodal Medical Management (MMM; using intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol lowering medications, and other rehabilitative measures, as indicated) without EVT, and 2) EVT with the background of MMM.\n\nTESTED will enroll patients with LVO-AIS who have a pre-existing disability, defined as pre-stroke modified Rankin score (mRS) 3 and 4, at 12 geographically distinct comprehensive stroke centers serving diverse race-ethnic and socioeconomic populations. The central objective of TESTED is to determine the comparative effectiveness and safety of these two different practice paradigms.",[18,19,20],"Stroke","Stroke, Acute","Stroke, Ischemic",[],"OBSERVATIONAL",null,[],{"count":26,"type":27},1060,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"PROCEDURE","Endovascular Stroke Treatment","Patients who receive endovascular stroke treatment when they are admitted into the hospital, as determined by their clinical care team. Endovascular stroke treatment consist of catheter-based treatment for the blood clot causing the acute ischemic stroke",[34],"Stroke patients with moderate-to-severe pre-stroke disability",{"type":13,"name":36,"description":37,"armGroupLabels":38},"Medical Management","Patients who receive MMM when they are admitted into the hospital, as determined by their clinical care team. MMM may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care. Specifically, this treatment does not involve endovascular stroke treatment.",[34],[40],{"measure":41,"description":42,"timeFrame":43},"modified Rankin Scale (mRS)","Score of 0-3, 4, 5 or 6 on the modified Rankin Scale (mRS) (Note: mRS range: 0 (no residual symptoms) to 6 (death)","90 (±14) days after treatment initiation",[45,48,51,54],{"measure":46,"description":47,"timeFrame":43},"Disability-weighted (or utility-weighted) mRS","Standard utility weights applied to the mRS categories as follows: 1.0 for mRS level 0; 0.91 for mRS level 1; 0.76 for mRS level 2; 0.65 for mRS level 3; 0.33 for mRS level 4; 0 for mRS level 5; and 0 for mRS level 6",{"measure":49,"description":50,"timeFrame":43},"Return to the pre-stroke mRS level","Returning to the pre-stroke mRS level post stroke",{"measure":52,"description":53,"timeFrame":43},"EQ-5D-5L","Quality of life assessment scale with range: 0 (worst health) to 100 (best health)",{"measure":55,"description":56,"timeFrame":43},"Academic Medical Center - Linear Disability Scale (ALDS)","Generic item bank that measures the disability status of patients with a broad range of diseases, as expressed by the ability to perform activities in daily living.","ALL","18 Years",false,{"inclusion":61,"exclusion":62,"raw_text":63},[],[],"Inclusion Criteria:\n\n1. Adult patients (≥18 years)\n2. Moderate-to-severe pre-stroke functional disability, defined as mRS 3-4, for at least 3 months prior to stroke onset\n3. Presenting to study hospital within 24 hours of last known well time\n4. Diagnosis of acute ischemic stroke\n5. Intracranial causative occlusion of the internal carotid artery or the M1 or dominant M2 segments of the middle cerebral artery visualized on the baseline CT(or MR) angiogram\n6. Presenting CT Alberta Stroke Program Early CT (ASPECT) score ≥3 or MRI ASPECT score ≥4\n7. Presenting NIH Stroke Scale score ≥6\n8. Informed consent from patient if competent or from legally authorized representative\n\nExclusion Criteria:\n\n1. Known diagnosis of a terminal cancer or terminal illness at the time of stroke\n2. Assessment of pre-stroke functional status cannot be performed during the hospital stay\n3. Pre-stroke disability deemed temporary in the investigator's opinion (for example, recovering from a general medical illness or traumatic bodily injury)",[65,66],"ADULT","OLDER_ADULT",[68,83,95,103,113,123,135,147,158,170,182,193,204,217,225,237,247,255,267,279,291,303,314,326,338],{"facility":69,"status":7,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":80},"HonorHealth","Phoenix","Arizona","85013","United States",[75,78],{"name":76,"role":77},"Ashu Jadhav, MD","CONTACT",{"name":76,"role":79},"PRINCIPAL_INVESTIGATOR",{"lat":81,"lon":82},33.44838,-112.07404,{"facility":84,"status":7,"city":85,"state":86,"zip":87,"country":73,"contacts":88,"geoPoint":92},"Kaiser Permanente Los Angeles Medical Center","Los Angeles","California","90027",[89,91],{"name":90,"role":77},"Shayandokht Taleb, MD",{"name":90,"role":79},{"lat":93,"lon":94},34.05223,-118.24368,{"facility":96,"status":7,"city":85,"state":86,"zip":97,"country":73,"contacts":98,"geoPoint":102},"University of California at Los Angeles","90095",[99,101],{"name":100,"role":77},"Jeffrey Saver, MD",{"name":100,"role":79},{"lat":93,"lon":94},{"facility":104,"status":7,"city":105,"state":86,"zip":106,"country":73,"contacts":107,"geoPoint":110},"Standford","Palo Alto","94305",[108],{"name":109,"role":77},"Maarten Lansberg, MD",{"lat":111,"lon":112},37.44188,-122.14302,{"facility":114,"status":7,"city":115,"state":86,"zip":116,"country":73,"contacts":117,"geoPoint":120},"University of Cincinnati San Diego","San Diego","92121",[118],{"name":119,"role":77},"Brett Meyer, MD",{"lat":121,"lon":122},32.71571,-117.16472,{"facility":124,"status":7,"city":125,"state":126,"zip":127,"country":73,"contacts":128,"geoPoint":132},"Swedish Medical Center","Englewood","Colorado","80113",[129,131],{"name":130,"role":77},"Donald Frei, MD",{"name":130,"role":79},{"lat":133,"lon":134},39.64777,-104.98776,{"facility":136,"status":7,"city":137,"state":138,"zip":139,"country":73,"contacts":140,"geoPoint":144},"Hartford Health Hospital","Hartford","Connecticut","06106",[141,143],{"name":142,"role":77},"Tapan Mehta, MD",{"name":142,"role":79},{"lat":145,"lon":146},41.76371,-72.68509,{"facility":148,"status":7,"city":149,"state":138,"zip":150,"country":73,"contacts":151,"geoPoint":155},"Yale University","New Haven","06510",[152,154],{"name":153,"role":77},"Adam DeHavenon, MD",{"name":153,"role":79},{"lat":156,"lon":157},41.30815,-72.92816,{"facility":159,"status":7,"city":160,"state":161,"zip":162,"country":73,"contacts":163,"geoPoint":167},"University of Miami","Miami","Florida","33125",[164,166],{"name":165,"role":77},"Robert Starke, MD",{"name":165,"role":79},{"lat":168,"lon":169},25.77427,-80.19366,{"facility":171,"status":7,"city":172,"state":173,"zip":174,"country":73,"contacts":175,"geoPoint":179},"Emory University","Atlanta","Georgia","30322",[176,178],{"name":177,"role":77},"Brian Howard, MD",{"name":177,"role":79},{"lat":180,"lon":181},33.749,-84.38798,{"facility":183,"status":7,"city":184,"state":185,"zip":186,"country":73,"contacts":187,"geoPoint":190},"University of Chicago","Chicago","Illinois","60637",[188],{"name":189,"role":77},"James Siegler, MD",{"lat":191,"lon":192},41.85003,-87.65005,{"facility":194,"status":7,"city":195,"state":196,"zip":197,"country":73,"contacts":198,"geoPoint":201},"University of Louisville","Louisville","Kentucky","40202",[199],{"name":200,"role":77},"Isaac Josh Abecassis",{"lat":202,"lon":203},38.25424,-85.75941,{"facility":205,"status":7,"city":206,"state":207,"zip":208,"country":73,"contacts":209,"geoPoint":214},"Boston Medical Center","Boston","Massachusetts","02118",[210,212],{"name":211,"role":77},"Mohamad AbdalKader, MD",{"name":213,"role":79},"Mohamad AbdalKader",{"lat":215,"lon":216},42.35843,-71.05977,{"facility":218,"status":7,"city":219,"state":220,"zip":221,"country":73,"contacts":222},"Barnes Jewish Hospital","Saint Loius","Missouri","63110",[223],{"name":224,"role":77},"Charles Kircher, MD",{"facility":226,"status":7,"city":227,"state":228,"zip":229,"country":73,"contacts":230,"geoPoint":234},"New York University","Brooklyn","New York","11220",[231,233],{"name":232,"role":77},"Aaron Lord",{"name":232,"role":79},{"lat":235,"lon":236},40.6501,-73.94958,{"facility":238,"status":7,"city":228,"state":228,"zip":239,"country":73,"contacts":240,"geoPoint":244},"Icahn School of Medicine at Mount Sinai","10029",[241,243],{"name":242,"role":77},"Shahram Majidi, MD",{"name":242,"role":79},{"lat":245,"lon":246},40.71427,-74.00597,{"facility":248,"status":7,"city":228,"state":228,"zip":249,"country":73,"contacts":250,"geoPoint":254},"Columbia University","10032",[251,253],{"name":252,"role":77},"Joshua Wiley, MD",{"name":252,"role":79},{"lat":245,"lon":246},{"facility":256,"status":7,"city":257,"state":258,"zip":259,"country":73,"contacts":260,"geoPoint":264},"University of Cincinnati Medical Center","Cincinnati","Ohio","45219",[261,263],{"name":262,"role":77},"Stacie Demel, DO, PhD",{"name":262,"role":79},{"lat":265,"lon":266},39.12711,-84.51439,{"facility":268,"status":7,"city":269,"state":270,"zip":271,"country":73,"contacts":272,"geoPoint":276},"Providence St. Vincent Medical Center","Portland","Oregon","97225",[273,275],{"name":274,"role":77},"Amit Kansara, MD",{"name":274,"role":79},{"lat":277,"lon":278},45.52345,-122.67621,{"facility":280,"status":7,"city":281,"state":282,"zip":283,"country":73,"contacts":284,"geoPoint":288},"University of Pittsburgh Medical Center","Pittsburgh","Pennsylvania","15213",[285,287],{"name":286,"role":77},"Raul Nogueira, MD",{"name":286,"role":79},{"lat":289,"lon":290},40.44062,-79.99589,{"facility":292,"status":7,"city":293,"state":294,"zip":295,"country":73,"contacts":296,"geoPoint":300},"Baptist Memorial Hospital","Memphis","Tennessee","38120",[297,299],{"name":298,"role":77},"Violiza Inoa, MD",{"name":298,"role":79},{"lat":301,"lon":302},35.14953,-90.04898,{"facility":304,"status":7,"city":305,"state":294,"zip":306,"country":73,"contacts":307,"geoPoint":311},"Vanderbilt University Medical Center","Nashville","37232",[308,310],{"name":309,"role":77},"Deborah Kerrigan, MD",{"name":309,"role":79},{"lat":312,"lon":313},36.16589,-86.78444,{"facility":315,"status":7,"city":316,"state":317,"zip":318,"country":73,"contacts":319,"geoPoint":323},"University of Texas at Austin","Austin","Texas","78712",[320,322],{"name":321,"role":77},"Hamidreza Saber, MD",{"name":321,"role":79},{"lat":324,"lon":325},30.26715,-97.74306,{"facility":327,"status":7,"city":328,"state":329,"zip":330,"country":73,"contacts":331,"geoPoint":335},"University of Washington","Seattle","Washington","98104",[332,334],{"name":333,"role":77},"David Tirschwell, MD",{"name":333,"role":79},{"lat":336,"lon":337},47.60621,-122.33207,{"facility":339,"status":7,"city":340,"state":341,"zip":342,"country":73,"contacts":343,"geoPoint":347},"West Virginia University","Morgantown","West Virginia","26506",[344,346],{"name":345,"role":77},"Ansaar Rai, MD",{"name":345,"role":79},{"lat":348,"lon":349},39.62953,-79.9559,[351,355],{"name":352,"role":77,"phone":353,"email":354},"Eva Mistry, MD","513-558-1291","mistryea@ucmail.uc.edu",{"name":356,"role":77,"phone":357,"email":358},"Naima Griffin","513-558-0125","griffna@ucmail.uc.edu",[360,361,363,365],{"name":352,"affiliation":12,"role":79},{"name":100,"affiliation":362,"role":79},"Ronald Reagan UCLA Medical Center",{"name":364,"affiliation":238,"role":79},"J Mocco, MD",{"name":366,"affiliation":12,"role":79},"Heidi Sucharew, PhD",[],[],{"nct_id":4,"conditions":370,"biomarkers":372},[371],"Ischemic Stroke",[],{"nct_id":4,"found":14,"summary":374,"prompt_version":384},{"design":375,"status":376,"heading":377,"summary":378,"follow_up":379,"word_count":380,"commitments":381,"compensation":382,"drugs_mentioned":383},"This is an observational study, meaning researchers will look at existing medical care rather than assigning treatments. It aims to include 1060 participants.","completed","Observational Study on Stroke Treatment for Patients with Existing Disability","This study, called TESTED, is looking at how well two different treatments work for people who have had a stroke (acute ischemic stroke) and already have some disability. It compares Endovascular Stroke Treatment (a procedure to remove blood clots from the brain) with Medical Management (which can include medications like intravenous thrombolysis, antiplatelets, and blood pressure drugs, plus rehabilitation). You might be able to join if you are an adult, have a moderate to severe disability before your stroke, and arrive at the hospital within 24 hours of your stroke symptoms starting. The main goal is to see how your functional ability changes 90 days after treatment. The study is currently unclear on its recruitment status.","Your functional ability will be checked about 90 days after your treatment starts.",116,"Not specified in the trial record.","Not stated in the trial record.",[31,36],"v2"]