[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05871606":3,"trial-entities:NCT05871606":125,"trial-summary:NCT05871606":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":45,"secondary_outcomes":50,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":87,"locations":90,"central_contacts":110,"overall_officials":120,"references":123,"see_also_links":124},"NCT05871606","IRB00090271","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","RECRUITING","2028-12-01","2026-04","2026-04-23","2026-04-16","Wake Forest University Health Sciences","OTHER",true,"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).","This dose escalation phase I study is to evaluate the safety and feasibility of iNO as adjunctive therapy in the treatment of AIS in adult patients with clinically significant strokes.\n\niNO will act as a selective vasodilator to ischemic tissues in the brain, increasing perfusion to the area of the brain most at risk (penumbra) in AIS patients. This therapy will help to increase collateral circulation and perfusion to the penumbra, salvaging this tissue and limiting the volume of core infarct while mitigating reperfusion injury to the salvaged tissue.\n\nProtection of ischemic penumbra is paramount in IAMT stroke patients. IAMT to re-establish blood flow during AIS from a large vessel occlusion (LVO) reduces death and disability. Initially this intervention was recommended up until 6 hours after symptom onset, but more recently has proven safe and effective up to 16 and 24 hours after stroke onset in select patients. These studies have confirmed the long believed thought that supporting ischemic penumbra during AIS helps limit the size of the ultimate core infarct and therefore reduces disability and death from stroke. Treatment aimed at protecting ischemic penumbra is thus paramount to treatment and research endeavors in AIS patients.\n\niNO protects ischemic penumbra. Nitric oxide is an endothelial-derived vasodilator and has been shown to mediate cytoprotection after ischemic reperfusion injury and appears to aid in ischemic preconditioning signaling pathways. iNO has been shown to cause selective dilation of arterioles in the ischemic penumbra of stroke and subarachnoid hemorrhage animal models, helping augment the cerebral microcirculation and improve penumbral blood flow. This has been shown to reduce ischemic brain damage, limit core infarct, and consistently improve neurological outcome in a middle cerebral artery AIS mouse model",[19,20],"Cerebrovascular Disorders","Acute Cerebrovascular Disease",[22,23,24],"Stroke","blood clot extraction","large vessel occlusion","INTERVENTIONAL","TREATMENT",[28],"PHASE1",{"count":30,"type":31},36,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":44},"DRUG","iNO","Inhaled Nitrous Oxide",[38,39,40,41,42,43],"Dose 1 Group","Dose 2 Group","Dose 3 Group","Dose 4 Group","Dose 5 Group","Dose 6 Group",[36],[46],{"measure":47,"description":48,"timeFrame":49},"Maximum safe dose of iNO for AIS patients - assessing for reperfusion hemorrhage\u002Fsymptomatic intracranial hemorrhage (sICH)","To establish a maximum safe dose of iNO for acute ischemic (non-bleeding) stroke (AIS) patients, assessing for reperfusion hemorrhage\u002Fsymptomatic intracranial hemorrhage (sICH)","Year 2",[51],{"measure":52,"description":53,"timeFrame":49},"Change in pre-endovascular mechanical thrombectomy (IAMT) and post-IAMT core infarct volume","Core infarct measurement pre\u002Fpost","ALL","18 Years","80 Years",false,{"inclusion":59,"exclusion":70,"raw_text":86},[60,61,62,63,64,65,66,67,68,69],"Age 18 and \\\u003C 80","Clinical evidence of acute ischemic (non-bleeding) stroke (AIS) with NIH Stroke Scale of 6 or higher","Non-contrast Computed tomography (CT) Head with ASPECT (Alberta Stroke Program Early CT) score 6","Symptom onset began \\\u003C 16 hours from initiation of intra-arterial mechanical thrombectomy (IAMT) procedure","CT Angiogram (CTA) evidence of anterior circulation MCA (Middle Cerebral Artery) M1 or dominant proximal M2 segment occlusion.","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","Patient or patient's representative provides consent","Pre-stroke modified Rankin Scale (mRS) of \\\u003C =2","General endotracheal anesthesia (GETA) is planned to be used, as standard care, for IAMT","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.",[71,72,73,74,75,76,77,78,79,80,81,82,83,84,85],"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","Inability to undergo a brain MRI (e.g., implanted pacemaker)","Patients who received IV tPA \\>4.5hrs after symptom onset","Coaguloapathy, defined as platelet count \\\u003C 50,000, INR \\>3.0, PTT \\> 3x normal, use of novel anticoagulants with eGFR \\\u003C 30ml\u002Fmin","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","Any form of hemorrhage on non-contrast CT Head or mass lesion","Severe head injury within 90 days","Pre-existing severe neurological\u002Fpsychiatric disease","Seizure at stroke onset (unable to assess NIHSS)","Blood glucose \\\u003C 50mg\u002FdL or \\>400mg\u002FdL","Hemoglobin \\\u003C7mmol\u002FL","eGFR \\\u003C 30ml\u002Fmin","Allergy to contrast media","Presumed septic embolus as source of stroke","Flow limiting intracranial or extracranial carotid stenosis, or complete carotid occlusion","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",[88,89],"ADULT","OLDER_ADULT",[91,104],{"facility":92,"status":8,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":101},"Carolinas Medical Center","Charlotte","North Carolina","28203","United States",[98],{"name":99,"role":100},"William Stetler, MD","PRINCIPAL_INVESTIGATOR",{"lat":102,"lon":103},35.22709,-80.84313,{"facility":105,"status":8,"city":93,"state":94,"zip":106,"country":96,"contacts":107,"geoPoint":109},"Atrium Health","28204",[108],{"name":99,"role":100},{"lat":102,"lon":103},[111,116],{"name":112,"role":113,"phone":114,"email":115},"Anna M Helms, MSN, RN","CONTACT","704-446-0473","anna.m.helms@advocatehealth.org",{"name":117,"role":113,"phone":118,"email":119},"Clara Schommer, CCRP","704-355-9434","clara.schommer@advocatehealth.org",[121],{"name":122,"affiliation":13,"role":100},"William R Stetler, MD",[],[],{"nct_id":4,"conditions":126,"biomarkers":128},[127],"Acute Ischemic Stroke",[],{"nct_id":4,"found":15,"summary":130,"prompt_version":140},{"design":131,"status":132,"heading":133,"summary":134,"follow_up":135,"word_count":136,"commitments":137,"compensation":138,"drugs_mentioned":139},"This is a dose escalation study to evaluate the safety and feasibility of inhaled nitric oxide. It plans to enroll 36 participants.","completed","Inhaled Nitric Oxide for Acute Ischemic Stroke During Mechanical Thrombectomy","This study is looking at the safety and feasibility of using inhaled nitric oxide (iNO) in patients who are having a mechanical thrombectomy (a procedure to remove blood clots) for an acute ischemic stroke (a stroke caused by a blood clot). The researchers want to see if iNO can help protect brain tissue that is at risk of damage during a stroke by increasing blood flow to that area. This study aims to find the safest dose of iNO for these patients. You might be able to join if you are between 18 and 80 years old, have had an acute ischemic stroke with a certain severity, and are undergoing mechanical thrombectomy within 16 hours of your stroke symptoms starting. The study plans to enroll 36 participants, but its current status is unclear.","The primary endpoint, assessing for reperfusion hemorrhage\u002Fsymptomatic intracranial hemorrhage, will be measured at Year 2.",133,"Not specified in the trial record.","Not stated in the trial record.",[35],"v2"]