Inhaled Nitric Oxide in Acute Ischemic Stroke Patients Undergoing Mechanical Thrombectomy

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05871606
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acute Cerebrovascular Disease
  • Cerebrovascular Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • iNO — DRUG
    Inhaled Nitrous Oxide

Study Details

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).

Key Dates

Start date
Apr 16, 2026
Status verified
Apr 2026
Primary completion
Aug 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose 2 Group
    Dose 2- Inhaled Nitrous Oxide (iNO) 40ppm.
  • Experimental: Dose 3 Group
    Dose 3- Inhaled Nitrous Oxide (iNO) 50ppm.
  • Experimental: Dose 4 Group
    Dose 4- Inhaled Nitrous Oxide (iNO) 60ppm.
  • Experimental: Dose 5 Group
    Dose 5- Inhaled Nitrous Oxide (iNO) 70ppm.
  • Experimental: Dose 6 Group
    Dose 6- Inhaled Nitrous Oxide (iNO) 80ppm.
  • Experimental: Dose 1 Group
    Dose 1- Inhaled Nitrous Oxide (iNO) 20ppm.

Primary Outcome Measure

Maximum safe dose of iNO for AIS patients - assessing for reperfusion hemorrhage/symptomatic intracranial hemorrhage (sICH) [ Time Frame: Year 2 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Atrium HealthCharlotteNorth Carolina28204
William Stetler, MD (PRINCIPAL_INVESTIGATOR)
Carolinas Medical CenterCharlotteNorth Carolina28203
William Stetler, MD (PRINCIPAL_INVESTIGATOR)

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By research site
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