Status:
UNKNOWN
NanO2 for Large Vessel Occlusion Stroke
Lead Sponsor:
NuvOx LLC
Collaborating Sponsors:
University of Arkansas
Stanford University
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
PHASE3
Brief Summary
A two stage phase 2 study with an interim analysis to provide evidence that subjects provided with early administration of NanO2 who are located at small rural spoke hospitals and identified with larg...
Detailed Description
Recent stroke studies have shown that subjects with Large Vessel Occlusion (LVO) ischemic stroke have rapid infarct growth. The investigators hypothesize that early administration of NanO2 in subjects...
Eligibility Criteria
Inclusion
- Ages 18 to 90 years old, male or female
- Diagnosis of LVO ischemic stroke
- Pre-stroke mRS ≤ 2
- NIHSS ≥ 6
- Eligible for mechanical thrombectomy per local criteria
- Subject or LAR must be willing and able to understand the study and provide written informed consent
- Women of childbearing potential or men with child-bearing potential partners (unless vasectomized) must agree to use a highly effective method of birth control from study entry until 4 months after completing study therapy. Should a study participant or their partner become pregnant or suspect a pregnancy they should inform the treating study physician immediately
Exclusion
- \> 12 hours since onset of stroke symptoms
- Currently pregnant or breastfeeding
- History of significantly impaired renal or hepatic function
- Severe hemorrhage or severe hemorrhagic stroke on CT scan. Mild or moderate changes of Fisher Grade 1 or 2 subarachnoid hemorrhage are allowed as are hemorrhagic transformation changes of Grade HI-1 and HI-224,25
- Unable to undergo a contrast brain perfusion scan with either MRI or CT
- Pre-stroke mRS \> 2 (See Appendix 3)
- Unstable angina, NYHA Class II or greater congestive heart failure
- Uncontrolled hypertension (Systolic BP ≥ 200 and/or Diastolic BP ≤ 120 mmHg)
- Uncontrolled arrhythmia or history of clinically significant arrhythmia within the past six (6) months (except atrial fibrillation)
- Current acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy.
- History of allergic reaction attributed to compounds of similar chemical composition to NanO2TM (see Investigator's Brochure).
- Subject has received any investigational drug within thirty (30) days prior to enrollment into the study
- Inability to comply with the study procedures
- History or evidence of any other clinically significant condition that, in the opinion of the investigator, might pose a safety risk to subjects or interfere with study procedures, evaluation, or completion
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05389748
Start Date
April 1 2023
End Date
September 1 2025
Last Update
May 25 2022
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