RecruitingPhase 3

Normobaric Oxygen in AIS Transferred for EVT

China1,500 participantsStarted 2024-12-13

Plain-language summary

The primary objective of this study is to estimate the efficacy and safety of NBO on 3-month functional outcome after acute ischemic stroke

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age at least 18 years old;
. Signs and symptoms are consistent with a new acute stroke, with low possibility of stroke mimics (e.g., no sudden coma, prior seizure disorder, suspected hypoglycemia);
. No prior stroke in the last 3 months;
. Time from stroke onset (last seen well) to randomization is within 9 hours;
. (1) Baseline NIHSS score at 6 or more and Intracranial ICA or MCA-M1 or MCA-M2 dominant occlusion, with or without tandem cervical carotid stenosis or tandem cervical occlusion, confirmed by preoperative CTA (or MRA, DSA) and consistent with signs and symptoms; or (2) Baseline NIHSS score at 6 or more with a hyperdense MCA sign on non-contrast CT; or (3) Baseline NIHSS score at 12 or more;
. NIHSS score 0 or 1 in the section of level of consciousness;
. No significant pre-stroke disability (pre-stroke mRS 0--1);
. ASPECTS at least 6 on non-contrast CT;

Exclusion criteria

. Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III or IV, acute pulmonary infection or aspiration pneumonia, prior to enrollment;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Level of disability measured by modified Rankin scale (mRS) score

Timeframe: 90 days, 1 year after randomization

Trial details

NCT IDNCT06666764

SponsorCapital Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Lan Liu, PhD

8683911991 liulan1815@outlook.com

View on ClinicalTrials.gov More Ischemic Stroke trials