Inhaled Nitric Oxide for Ischemic Stroke
(iNO Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byWilliam R Stetler, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Trial Summary

What is the purpose of 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

This trial is for adults aged 18-79 who've had a recent ischemic stroke and are undergoing mechanical thrombectomy. They should have had mild to moderate disability before the stroke, show significant symptoms, and be within 16 hours of symptom onset. Patients with severe kidney issues, allergies to contrast media, extreme blood sugar levels or certain other health conditions are excluded.

Inclusion Criteria

I have had a stroke that wasn't caused by bleeding and my condition is serious.

You have had a CT scan of your head without contrast, and the ASPECT score is 6 or lower.

My stroke symptoms started less than 16 hours before my clot removal procedure.

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Exclusion Criteria

Inability to undergo a brain MRI (e.g., implanted pacemaker)

I am not in a vulnerable group such as being mentally ill, a prisoner, terminally ill, pregnant, or a child.

I have a blockage in my brain or neck arteries.

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Treatment Details

Interventions

iNO (Vasodilator)

Trial OverviewThe study tests the safety and effectiveness of inhaled nitric oxide (iNO) in patients having a procedure called intra-arterial mechanical thrombectomy to remove blood clots caused by an acute ischemic stroke. Participants must require general anesthesia during this procedure.

Participant Groups

5Treatment groups

Experimental Treatment

Group I: Dose 5 GroupExperimental Treatment1 Intervention

Dose 5- Inhaled Nitrous Oxide (iNO) 80ppm.

Group II: Dose 4 GroupExperimental Treatment1 Intervention

Dose 4- Inhaled Nitrous Oxide (iNO) 70ppm.

Group III: Dose 3 GroupExperimental Treatment1 Intervention

Dose 3- Inhaled Nitrous Oxide (iNO) 60ppm.

Group IV: Dose 2 GroupExperimental Treatment1 Intervention

Dose 2- Inhaled Nitrous Oxide (iNO) 50ppm.

Group V: Dose 1 GroupExperimental Treatment1 Intervention