NanO2 in Large VessEL Occlusion Stroke (NOVEL)

Launched by NHS GREATER GLASGOW AND CLYDE · Feb 10, 2025

Keywords

ClinConnect Summary

The NOVEL trial is studying a new treatment called NanO2, which may help reduce brain damage caused by a type of stroke known as ischemic stroke. In this type of stroke, a clot blocks blood flow to the brain, depriving it of oxygen and nutrients. NanO2 is designed to carry extra oxygen to the brain tissue, potentially keeping it healthy while doctors work to remove the clot using treatments like clot-busting drugs or procedures to open the blocked artery. The trial will include participants who have had a stroke within the past 9 hours and who meet certain health criteria, such as being at least 18 years old and having specific imaging results.

If you qualify and choose to participate, you will receive treatment as soon as possible after your stroke. The study will take place in 8-15 hospitals across the UK, and your involvement will last about 90 days, with most assessments happening during your hospital stay in the first 5 days. After you leave the hospital, there will be follow-up phone calls at 30 days and 90 days to check on your progress. It's important to know that this trial is not yet recruiting participants, but it offers a chance to be part of research that could lead to better stroke treatments in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or non-pregnant female aged ≥ 18 years
• • 2. Acute ischemic stroke fulfilling perfusion imaging criteria (ischemic core volume \< 70 mL, mismatch ratio \> 1.8 and mismatch volume \> 15 mL using RAPID or equivalent CE-marked software)
• • 3. Eligible for thrombolysis or thrombectomy
• • 4. Intracranial LVO on CTA (occlusion of the terminal ICA, MCA-M1, ≥1 proximal MCA-M2, or proximal posterior cerebral artery (PCA-P1))
• • 5. ≤ 9 hours after last known well (if waking with symptoms, last known well time is calculated as the mid-point between going to sleep and waking)
• • 6. Pre-stroke functional independence (estimated pre-stroke mRS ≤2)
• • 7. NIHSS score ≥ 6 (or NIHSS ≥ 2 if PCA-P1 occlusion) at randomisation
• Exclusion Criteria:
• • 1. History of significantly impaired renal eGFR (\<30ml/min) or hepatic function (transaminases \>3 times upper limit of normal or history of cirrhosis), unstable angina or heart failure (NYHA 3 or 4).
• • 2. Pre-existing lung disease requiring supplemental chronic or intermittent oxygen therapy (NB oxygen therapy given post-stroke is not an exclusion)
• • 3. Previous hypersensitivity reaction to NanO2 excipients and/or compounds similar to NanO2
• • 4. Pregnancy (for women of child-bearing potential a negative pregnancy test will be required prior to randomisation) or breast feeding women.
• • Women of child-bearing potential is defined as experienced menarche; AND not undergone successful surgical sterilisation (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy); AND not post-menopausal i.e. amenorrhea for ≥12 consecutive months (without another medical cause)
• • 5. Participation in another CTIMP within preceding 90 days or 5 half-lives of the investigational product, whichever is longer, or previous participation in NOVEL.