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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.

Study design
This is a dose escalation study to evaluate the safety and feasibility of inhaled nitric oxide. It plans to enroll 36 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, assessing for reperfusion hemorrhage/symptomatic intracranial hemorrhage, will be measured at Year 2.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05871606

Inhaled Nitric Oxide in Acute Ischemic Stroke Patients Undergoing Mechanical Thrombectomy

Recruiting
PHASE1Ages 18–80InterventionalTreatment
Wake Forest University Health Sciences
~36 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:iNO

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum safe dose of iNO for AIS patients - assessing for reperfusion hemorrhage/symptomatic intracranial hemorrhage (sICH)
Measured over Year 2

Conditions

Cerebrovascular Disorders
Acute Cerebrovascular Disease

Explore related trials

Acute Ischemic Stroke

NCT05871606

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Atrium Health

    Charlotte, North Carolinano site contact published

    Recruiting

  • Carolinas Medical Center

    Charlotte, North Carolinano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • William R Stetler, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Anna M Helms, MSN, RN
[email protected]
704-446-0473
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Maximum safe dose of iNO for AIS patients - assessing for reperfusion hemorrhage/symptomatic intracranial hemorrhage (sICH)Year 2

    To establish a maximum safe dose of iNO for acute ischemic (non-bleeding) stroke (AIS) patients, assessing for reperfusion hemorrhage/symptomatic intracranial hemorrhage (sICH)