Recruiting
Phase 1

Inhaled Nitric Oxide

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05871606

Conditions

Cerebrovascular Disorders

Acute Cerebrovascular Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

iNO

Study Details

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).

Conditions

Cerebrovascular Disorders

Acute Cerebrovascular Disease

Study ID

NCT05871606

Start date

Apr 16, 2026

Status verified date

Apr, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose 2 Group

Dose 2- Inhaled Nitrous Oxide (iNO) 40ppm.

experimental: Dose 3 Group

Dose 3- Inhaled Nitrous Oxide (iNO) 50ppm.

experimental: Dose 4 Group

Dose 4- Inhaled Nitrous Oxide (iNO) 60ppm.

experimental: Dose 5 Group

Dose 5- Inhaled Nitrous Oxide (iNO) 70ppm.

experimental: Dose 6 Group

Dose 6- Inhaled Nitrous Oxide (iNO) 80ppm.

experimental: Dose 1 Group

Dose 1- Inhaled Nitrous Oxide (iNO) 20ppm.

Interventions

iNO

Inhaled Nitrous Oxide

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Anna M Helms, MSN, RN

704-446-0473anna.m.helms@advocatehealth.org

Clara Schommer, CCRP

704-355-9434clara.schommer@advocatehealth.org

Locations

Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28203

Principal Investigator:

William Stetler, MD

Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28204

Principal Investigator:

William Stetler, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Stroke
  • blood clot extraction
  • large vessel occlusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-04-23.