Inhaled nitric oxide during mechanical clot removal for acute ischemic stroke
Inhaled Nitric Oxide in Acute Ischemic Stroke Patients Undergoing Mechanical Thrombectomy: A Phase I Drug Pilot Research Plan
PHASE1 · Wake Forest University Health Sciences · NCT05871606
This test gives inhaled nitric oxide during mechanical clot removal to adults with acute ischemic stroke to see if it is safe and can help protect vulnerable brain tissue.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences (other) |
| Locations | 2 sites (Charlotte, North Carolina and 1 other locations) |
| Trial ID | NCT05871606 on ClinicalTrials.gov |
What this trial studies
This Phase 1 dose-escalation study tests the safety and feasibility of inhaled nitric oxide (iNO) as an add-on treatment during intra-arterial mechanical thrombectomy for adults with acute ischemic large vessel occlusion stroke. iNO will be delivered during the thrombectomy procedure under general endotracheal anesthesia and mechanical ventilation, with doses increased across cohorts to identify tolerability. Eligible patients must meet imaging criteria (ASPECTS ≥6, core infarct <70 ml, penumbra-to-core ratio ≥1.8 and penumbra ≥15 ml) and present within 16 hours of symptom onset. The primary focus is on safety and feasibility, with imaging and clinical outcomes used to monitor effects on ischemic penumbra and reperfusion injury.
Who should consider this trial
Good fit: Adults aged 18 to under 80 with an acute anterior circulation large vessel occlusion stroke who are planned for mechanical thrombectomy under general anesthesia and meet the study's CT/CTP imaging criteria within 16 hours of symptom onset.
Not a fit: Patients with hemorrhagic stroke, a large core infarct (>70 ml) or low ASPECTS (<6), posterior circulation occlusions, those treated beyond 16 hours, or those not receiving general endotracheal anesthesia/mechanical ventilation are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, inhaled nitric oxide given during clot removal could increase blood flow to at-risk brain tissue, reduce final infarct size, and improve recovery after stroke.
How similar studies have performed: Preclinical studies and limited clinical work suggest nitric oxide can protect ischemic tissue and reduce reperfusion injury, but using inhaled nitric oxide during mechanical thrombectomy is a novel approach that is not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charlotte, North Carolina and 1 other locations
- Carolinas Medical Center — Charlotte, North Carolina, United States (RECRUITING)
- Atrium Health — Charlotte, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: William R Stetler, MD — Wake Forest University Health Sciences
- Study coordinator: Anna M Helms, MSN, RN
- Email: anna.m.helms@advocatehealth.org
- Phone: 704-446-0473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebrovascular Disorders, Acute Cerebrovascular Disease, Stroke, blood clot extraction, large vessel occlusion