Inhaled Nitric Oxide in Acute Ischemic Stroke Patients Undergoing Mechanical Thrombectomy

ConditionsCerebrovascular Disorders Acute Cerebrovascular Disease

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-80

SponsorWake Forest University Health Sciences

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

Treatment groups

36 Participants

are divided into 6 treatment groups

Treatment groups

See each treatment group below.

Sponsors and collaborators

Wake Forest University Health Sciences

Lead sponsor

Source ClinicalTrials.gov