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New treatment option for Cerebrovascular Disorders
Official title Inhaled Nitric Oxide in Acute Ischemic Stroke Patients Undergoing Mechanical Thrombectomy
ClinicalTrials.gov ID: NCT05871606
What this study is testing
What is iNO?
iNO is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for cerebrovascular disorders.
Also referred to as Inhaled Nitrous Oxide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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.
You likely can't join if
- Hypotension at presentation, defined as systolic blood pressure (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 \ 3.0, PTT \> 3x normal, use of novel anticoagulants with eGFR \< 30ml/min
- Vulnerable people including: mentally ill or incompetent patients, those with diminished decision-making capacity, prisoners, inpatient care for...
- Any form of hemorrhage on non-contrast CT Head or mass lesion
See the full eligibility 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...
- Hypotension at presentation, defined as systolic blood pressure (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 \ 3.0, PTT \> 3x normal, use of novel anticoagulants with eGFR \< 30ml/min
- Vulnerable people 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 \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Charlotte, North Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlotte, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.