Inhaled Nitric Oxide in Acute Ischemic Stroke Patients Undergoing Mechanical Thrombectomy
iNO
1 other identifier
interventional
36
1 country
2
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2026
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2023
CompletedFirst Posted
Study publicly available on registry
May 23, 2023
CompletedStudy Start
First participant enrolled
April 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
April 23, 2026
April 1, 2026
2.3 years
May 12, 2023
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum safe dose of iNO for AIS patients - assessing for reperfusion hemorrhage/symptomatic intracranial hemorrhage (sICH)
To establish a maximum safe dose of iNO for acute ischemic (non-bleeding) stroke (AIS) patients, assessing for reperfusion hemorrhage/symptomatic intracranial hemorrhage (sICH)
Year 2
Secondary Outcomes (1)
Change in pre-endovascular mechanical thrombectomy (IAMT) and post-IAMT core infarct volume
Year 2
Study Arms (6)
Dose 2 Group
EXPERIMENTALDose 2- Inhaled Nitrous Oxide (iNO) 40ppm.
Dose 3 Group
EXPERIMENTALDose 3- Inhaled Nitrous Oxide (iNO) 50ppm.
Dose 4 Group
EXPERIMENTALDose 4- Inhaled Nitrous Oxide (iNO) 60ppm.
Dose 5 Group
EXPERIMENTALDose 5- Inhaled Nitrous Oxide (iNO) 70ppm.
Dose 6 Group
EXPERIMENTALDose 6- Inhaled Nitrous Oxide (iNO) 80ppm.
Dose 1 Group
EXPERIMENTALDose 1- Inhaled Nitrous Oxide (iNO) 20ppm.
Interventions
Inhaled Nitrous Oxide
Eligibility Criteria
You may qualify if:
- Age 18 and \< 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 \< 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 \< 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 \< =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.
You may not qualify if:
- Hypotension at presentation, defined as systolic blood pressure (SBP) \< 100 or MAP \< 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 \< 50,000, INR \>3.0, PTT \> 3x normal, use of novel anticoagulants with eGFR \< 30ml/min
- 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/psychiatric disease
- Seizure at stroke onset (unable to assess NIHSS)
- Blood glucose \< 50mg/dL or \>400mg/dL
- Hemoglobin \<7mmol/L
- eGFR \< 30ml/min
- Allergy to contrast media
- Presumed septic embolus as source of stroke
- Flow limiting intracranial or extracranial carotid stenosis, or complete carotid occlusion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Atrium Health
Charlotte, North Carolina, 28204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William R Stetler, MD
Wake Forest University Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2023
First Posted
May 23, 2023
Study Start
April 16, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share