[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506224":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":41,"centralContacts":45,"locations":56,"responsibleParty":82,"collaborators":50,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":37,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":50,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":59,"whyStopped":50,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose 2 Group","EXPERIMENTAL","Dose 2- Inhaled Nitrous Oxide (iNO) 40ppm.",[13],"Drug: iNO",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose 3 Group","Dose 3- Inhaled Nitrous Oxide (iNO) 50ppm.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Dose 4 Group","Dose 4- Inhaled Nitrous Oxide (iNO) 60ppm.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Dose 5 Group","Dose 5- Inhaled Nitrous Oxide (iNO) 70ppm.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Dose 6 Group","Dose 6- Inhaled Nitrous Oxide (iNO) 80ppm.",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Dose 1 Group","Dose 1- Inhaled Nitrous Oxide (iNO) 20ppm.",[13],[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","iNO","Inhaled Nitrous Oxide",[31,9,15,19,23,27],[38],[42],{"name":43,"affiliation":5,"role":44},"William R Stetler, MD","PRINCIPAL_INVESTIGATOR",[46,52],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},"Anna M Helms, MSN, RN","CONTACT","704-446-0473",null,"anna.m.helms@advocatehealth.org",{"name":53,"role":48,"phone":54,"phoneExt":50,"email":55},"Clara Schommer, CCRP","704-355-9434","clara.schommer@advocatehealth.org",[57,74],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Carolinas Medical Center","RECRUITING","Charlotte","North Carolina","28203","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-80.84313,35.22709,{"lat":69,"lon":68},[72],{"name":73,"role":44,"phone":50,"phoneExt":50,"email":50},"William Stetler, MD",{"facility":75,"status":59,"city":60,"state":61,"zip":76,"country":63,"countryCode":64,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"Atrium Health","28204",{"type":66,"coordinates":78},[68,69],{"lat":69,"lon":68},[81],{"name":73,"role":44,"phone":50,"phoneExt":50,"email":50},{"type":83,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100506224","phase-1-inhaled-nitric-oxide-in-acute-ischemic-stroke-patients-undergoing-mechanical-thrombectomy-100506224",false,"NCT05871606","Inhaled Nitric Oxide in Acute Ischemic Stroke Patients Undergoing Mechanical Thrombectomy","Inhaled Nitric Oxide in Acute Ischemic Stroke Patients Undergoing Mechanical Thrombectomy: A Phase I Drug Pilot Research Plan","Inclusion Criteria:\n\n* Age 18 and \\\u003C 80\n* Clinical evidence of acute ischemic (non-bleeding) stroke (AIS) with NIH Stroke Scale of 6 or higher\n* Non-contrast Computed tomography (CT) Head with ASPECT (Alberta Stroke Program Early CT) score 6\n* Symptom onset began \\\u003C 16 hours from initiation of intra-arterial mechanical thrombectomy (IAMT) procedure\n* CT Angiogram (CTA) evidence of anterior circulation MCA (Middle Cerebral Artery) M1 or dominant proximal M2 segment occlusion.\n* CT Perfusion (CTP) evidence of core infarct volume of \\\u003C 70ml and a ratio of ischemic tissue to initial core infarct volume of 1.8 or greater, and an absolute volume of penumbra of 15ml or greater\n* Patient or patient's representative provides consent\n* Pre-stroke modified Rankin Scale (mRS) of \\\u003C =2\n* General endotracheal anesthesia (GETA) is planned to be used, as standard care, for IAMT\n* Treatment with iNO requires mechanical ventilation. Because IAMT can be performed using conscious sedation and not GETA, only those patients for which the procedure is planned with GETA will be included. The decision for the type of anesthetic depends on the severity of stroke, region of brain affected by the stroke, and the ability for the patient to cooperate for the procedure.\n\nExclusion Criteria:\n\n* Hypotension at presentation, defined as systolic blood pressure (SBP) \\\u003C 100 or MAP \\\u003C 60; profound hypertension with SBP \\>185 or DBP \\>110mmHg unable to be controlled with IV medications\n* Inability to undergo a brain MRI (e.g., implanted pacemaker)\n* Patients who received IV tPA \\>4.5hrs after symptom onset\n* Coaguloapathy, defined as platelet count \\\u003C 50,000, INR \\>3.0, PTT \\> 3x normal, use of novel anticoagulants with eGFR \\\u003C 30ml\u002Fmin\n* Vulnerable Subjects including: mentally ill or incompetent patients, those with diminished decision-making capacity, prisoners, inpatient care for long-term chronic illness, terminally ill, pregnant women, and children\n* Any form of hemorrhage on non-contrast CT Head or mass lesion\n* Severe head injury within 90 days\n* Pre-existing severe neurological\u002Fpsychiatric disease\n* Seizure at stroke onset (unable to assess NIHSS)\n* Blood glucose \\\u003C 50mg\u002FdL or \\>400mg\u002FdL\n* Hemoglobin \\\u003C7mmol\u002FL\n* eGFR \\\u003C 30ml\u002Fmin\n* Allergy to contrast media\n* Presumed septic embolus as source of stroke\n* Flow limiting intracranial or extracranial carotid stenosis, or complete carotid occlusion","ALL","18 Years","80 Years",{"count":95,"type":96},36,"ESTIMATED","INTERVENTIONAL",[99],"PHASE1","The purpose of this study is to determine the safety and feasibility of using inhaled nitric oxide (iNO) in patients undergoing intra-arterial mechanical thrombectomy (blood clot extraction or IAMT) for treatment of acute ischemic (non-bleeding) stroke (AIS).",[102,103],"Cerebrovascular Disorders","Acute Cerebrovascular Disease",[105,106,107],"Stroke","blood clot extraction","large vessel occlusion","2026-04-22",{"date":110,"type":111},"2026-04-23","ACTUAL",{"date":113,"type":111},"2026-04-16",{"date":115,"type":96},"2028-12-01",{"name":5,"class":6},2]