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

Apr 16, 2026

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This trial tests whether inhaled nitric oxide (iNO) — a gas that dilates blood vessels and is used in newborn respiratory care — can improve brain outcomes when administered during mechanical thrombectomy for acute ischemic stroke. During a major stroke, brain tissue is dying rapidly from lack of blood flow. Even after the blocked artery is reopened by thrombectomy, reperfusion injury (damage from blood suddenly rushing back) and residual microvascular spasm can limit recovery. Inhaled nitric oxide may help by improving blood flow to the small vessels of the brain and reducing this reperfusion damage. Eligible participants are adults aged 18–79 with a confirmed anterior circulation (MCA) stroke, NIH Stroke Scale ≥6, appropriate CT findings (ASPECT score ≥6, salvageable brain tissue on perfusion imaging), symptom onset within 16 hours, and a plan for general anesthesia during the procedure. Multiple exclusions apply: severe blood pressure extremes, pregnancy, severe bleeding disorders, recent tPA outside the window, coagulopathy, seizure at onset, extreme blood glucose, severe anemia, low kidney function, and others. Participants receive iNO during their procedure and are followed for functional neurological outcomes. This research is significant because even with thrombectomy — the best current stroke treatment — many patients have poor outcomes. An adjunctive therapy that protects brain tissue during and after reperfusion could translate into meaningful reductions in disability for one of the most devastating medical emergencies.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGiNO

Inhaled Nitrous Oxide


Locations(2)

Carolinas Medical Center

Charlotte, North Carolina, United States

Atrium Health

Charlotte, North Carolina, United States

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NCT05871606


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