Inhaled Nitric Oxide Tested for Stroke Patients Having Clot Removal
Tests inhaled nitric oxide safety in adults with acute ischemic stroke during clot removal.
Plain-language title generated from the registry record
Registry title: Inhaled Nitric Oxide in Acute Ischemic Stroke Patients Undergoing Mechanical Thrombectomy
Key facts
- Where
- Charlotte, United StatesSee the 2 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05871606, who can take part
Where in United States
- Atrium HealthCharlotte, United StatesTaking people
- Carolinas Medical CenterCharlotte, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Wake Forest University Health Sciences
- Trial code
- NCT05871606
- Record updated
- 23 April 2026
- Original description
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).Read full original descriptionShow less
Inhaled Nitric Oxide in Acute Ischemic Stroke Patients Undergoing Mechanical Thrombectomy: A Phase I Drug Pilot Research Plan
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).
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: Patients who received IV tPA >4.5hrs after symptom onset; 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; 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; Pre-existing severe neurological/psychiatric disease; Seizure at stroke onset (unable to assess NIHSS); Allergy to contrast media; Presumed septic embolus as source of stroke; Coaguloapathy, defined as platelet count < 50,000, INR >3.0, PTT > 3x normal, use of novel anticoagulants with eGFR < 30ml/min; Blood glucose < 50mg/dL or >400mg/dL; Hemoglobin <7mmol/L; eGFR < 30ml/min; Inability to undergo a brain MRI (e.g., implanted pacemaker); Severe head injury within 90 days; Flow limiting intracranial or extracranial carotid stenosis, or complete carotid occlusion.