NCT05871606RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 12 May 2023
- Start date
- 16 Apr 2026
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Stroke
- NCT number
- NCT05871606
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 36
- From 16 Apr 2026 to the primary completion date, 1 Aug 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who received IV tPA \>4.5hrs after symptom onset
Other illness
- 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
Lab values
- 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
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Carolinas Medical Center Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Atrium Health Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.