Could a direct brain artery injection improve stroke recovery?
NCT ID NCT06781385
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 2 trial tests whether giving the clot-busting drug tenecteplase directly into the brain artery after standard clot removal is safe and feasible for people with severe stroke. About 40 participants who had a large artery blockage will receive either the drug or a saltwater placebo. The study focuses on bleeding risks and survival at 30 and 90 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tenecteplase (a clot-busting drug)
- What this could lead to
- If it works, this could point toward a better way to clear remaining clots and improve recovery after a major stroke.
- What could go wrong
- This is a small, early-phase safety study (40 people). The drug may increase bleeding in the brain, and results may not apply to all stroke patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2025
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient/legally authorized representative has signed the Informed Consent Form * Ability to comply with the study protocol, in the investigator's judgment * Functionally independent (modified Rankin scale 0-2) prior to presentation * Baseline National Institutes of Health Stroke Scale (NIHSS) ≥ 6 * Clinical syndrome consistent with occlusion of the internal carotid artery (ICA) or proximal middle cerebral artery (MCA), presenting within 4.5- to 24-hours of TLKW * Evidence of ICA, MCA-M1, or MCA-M2 occlusion on baseline computed tomography angiogram (CTA) or magnetic resonance angiogram (MRA). ICA/MCA tandem occlusions may be enrolled * Alberta Stroke Program Early Computed Tomography Score ≥ 6 on pre-thrombectomy unenhanced CT as determined by treating neurologist or reading radiologist * Pre-thrombectomy CTP or MRP with core infarction (cerebral blood flow \< 30%) \< 70 ml, mismatch ratio ≥ 1.8, mismatch volume ≥ 15 ml (completed within 120 minutes of skin puncture for thrombectomy). If skin puncture occurs more than 120 minutes after the pre-thrombectomy CTP, enrollment may proceed at the PI's discretion. * Endovascular thrombectomy of ICA, MCA-M1 or MCA-M2 occlusion performed according to local standard of care, defined as at least completing the initial diagnostic angiogram * CTP performed with RAPID AI AngioFlowTM within 30 minutes of thrombectomy completion * Modified thrombolysis in cerebral infarction (mTICI) 2b-3 revascularization following endovascular thrombectomy (EVT) (or after initial diagnostic angiogram) * Presence of Tm \> 6 lesion on post-EVT CTP of adequate quality for interpretation in the distribution of the symptomatic occlusion Exclusion Criteria: * Current participation in another investigational drug or device study * Known hypersensitivity or allergy to any ingredients of tenecteplase * Active internal bleeding * Known bleeding diathesis (e.g., Alzheimer's patients taking lecanemab) * Systolic blood pressure \> 185 mm Hg or diastolic blood pressure \> 110 mm Hg after EVT, refractory to medical therapy * Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR \> 1.7 * Use of one of the new oral anticoagulants within the last 48 hours (dabigatran, rivaroxaban, apixaban, edoxaban) * Treatment with a thrombolytic within the last 3 months prior to randomization * Baseline platelet count \< 100,000/mcL (results must be available prior to treatment) * Baseline blood glucose \> 400 mg/dL (22.20 mmol/L) * Baseline blood glucose \< 50 mg/dL; needs to be normalized prior to randomization * Intracranial or intraspinal surgery or trauma within 2 months * Intracranial malignant neoplasm, arteriovenous malformation, or unsecured aneurysm \> 1 cm * Other serious, advanced, or terminal illness (investigator's judgment) or life expectancy is less than 6 months * History of acute ischemic stroke in the last 90 days * History of hemorrhagic stroke * Presumed septic embolus; suspicion of bacterial endocarditis * Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was to be performed * Pregnant * Acute intracranial hemorrhage on pre-thrombectomy imaging or suspected acute intracranial hemorrhage after EVT * Acute bilateral strokes on initial imaging * Multiple acute intracranial occlusions (except ICA/MCA) on initial CTA or MRA * Significant hemispheric mass effect or any amount of midline shift due to acute stroke * Placement of cervical carotid or intracranial stent during thrombectomy procedure requiring dual antiplatelet therapy
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute ischemic stroke are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Atrium Health Neurosciences Institute
Charlotte, North Carolina, 28207, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can PET scans reveal hidden heart inflammation after a stroke?
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?
- China builds national watchdog for brain blood vessel devices
- Can tiny neural exosomes help the brain heal after a severe stroke?
- Can a new antibody boost recovery after severe stroke?
- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better