Actively Recruiting

Phase 1
Age: 18Years - 80Years
All Genders
NCT05871606

Inhaled Nitric Oxide in Acute Ischemic Stroke Patients Undergoing Mechanical Thrombectomy

Led by Wake Forest University Health Sciences · Updated on 2026-04-23

36

Participants Needed

2

Research Sites

137 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Inhaled Nitric Oxide in Acute Ischemic Stroke Patients Undergoing Mechanical Thrombectomy

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 and under 80 years
  • Clinical evidence of acute ischemic (non-bleeding) stroke with NIH Stroke Scale of 6 or higher
  • Non-contrast CT head with ASPECT score of 6 or more
  • Symptom onset less than 16 hours before starting intra-arterial mechanical thrombectomy
  • CT Angiogram showing blockage in anterior circulation MCA M1 or dominant proximal M2 segment
  • CT Perfusion showing core infarct volume under 70ml, ischemic tissue to core infarct ratio of 1.8 or greater, and penumbra volume of 15ml or greater
  • Patient or representative provides consent
  • Pre-stroke modified Rankin Scale score of 2 or less
  • Planned use of general endotracheal anesthesia for mechanical thrombectomy
  • Treatment with inhaled nitric oxide requires mechanical ventilation and planned general anesthesia
Not Eligible

You will not qualify if you...

  • Low blood pressure at presentation (SBP less than 100 or MAP less than 60) or uncontrolled high blood pressure (SBP over 185 or DBP over 110)
  • Unable to undergo brain MRI (e.g., implanted pacemaker)
  • Received IV tPA more than 4.5 hours after symptom onset
  • Coagulopathy including platelet count under 50,000, INR over 3.0, PTT more than 3 times normal, or use of novel anticoagulants with low kidney function
  • Mentally ill, incompetent, prisoners, long-term inpatient, terminally ill, pregnant women, or children
  • Any bleeding or mass lesion seen on non-contrast CT head
  • Severe head injury in past 90 days
  • Pre-existing severe neurological or psychiatric disease
  • Seizure at stroke onset preventing stroke scale assessment
  • Blood glucose less than 50 mg/dL or greater than 400 mg/dL
  • Hemoglobin less than 7 mmol/L
  • Kidney function (eGFR) less than 30 ml/min
  • Allergy to contrast media
  • Presumed septic embolus causing stroke
  • Severe intracranial or extracranial carotid artery narrowing or complete carotid blockage

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Carolinas Medical Center

Charlotte, North Carolina, United States, 28203

Actively Recruiting

2

Atrium Health

Charlotte, North Carolina, United States, 28204

Actively Recruiting

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Research Team

A

Anna M Helms, MSN, RN

CONTACT

C

Clara Schommer, CCRP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

6

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