RecruitingPhase 1NCT05871606

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

Sponsor

Wake Forest University Health Sciences

Enrollment

36 participants

Start Date

Nov 11, 2025

Study Type

INTERVENTIONAL

Conditions

Cerebrovascular Disorders Acute Cerebrovascular Disease

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).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria10

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 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.

Exclusion Criteria15

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