New stroke treatment targets Medium-Sized clots
NCT ID NCT07336927
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether giving a clot-busting drug directly into the brain artery, plus possibly removing the clot with a device, helps people with medium-sized stroke clots. About 614 participants who cannot receive standard IV clot-busters will be randomly assigned to either the new procedure or best medical care alone. The goal is to see if the procedure leads to better recovery and less disability.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tenecteplase (TNK) given directly into the artery, plus possible mechanical clot removal
- What this could lead to
- If successful, this could offer a new treatment option for stroke patients with medium-sized clots who cannot receive standard clot-busting drugs through a vein.
- What could go wrong
- This is an early-stage trial with no phase assigned, so results are uncertain. The procedure carries risks like bleeding or vessel damage, and the benefit over standard care is not yet proven.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 614 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: 1. Age ≥ 18 y; 2. Diagnosed as acute ischemic stroke; 3. Isolated medium distal vessel occlusion (i.e. an occlusion of the M2, the M3/M4 segment of the MCA, the A1/ A2/A3 segment of the ACA or the P1/P2/P3 segment of the PCA) confirmed by CT or MR Angiography; 4. Time from onset (or last-seen-well) to randomization \< 24h; 5. Has not received intravenous thrombolysis and is considered unsuitable for it based on the treating clinician's assessment. 6. NIHSS ≥ 5, or NIHSS ≤ 4 with disabling deficit (e.g. severe aphasia, hemianopia, hemiplegia/loss of function in one side) or fluctuating symptoms at the time of randomization; 7. For patients within 6 h of onset: No visually apparent hypodensity is observed on non-contrast CT compared with the contralateral white matter, or no hyperintensity is seen on fluid-attenuated inversion recovery (FLAIR) imaging; For patients presenting 6-24 h after onset: A perfusion imaging-based ischemic core mismatch ratio \>1.2 and an infarct core volume \<50 mL are required; 8. Pre-stroke mRS ≤ 1; 9. Patient/Legally Authorized Representative has signed the Informed Consent form. Exclusion Criteria: 1. Any evidence of intracranial hemorrhage on qualifying imaging; 2. Concurrent multiple (≥2) intracranial arterial occlusions; 3. Suspected cerebral vasculitis, septic embolism, or infective endocarditis as the cause of vessel occlusion; 4. Suspected arterial dissection; 5. Clinical assessment of conditions unsuitable for interventional therapy (e.g., severe contrast agent allergy or absolute contraindications to iodine contrast agent; severe renal insufficiency, glomerular filtration rate \< 30ml/min or serum creatinine \> 220μmol/L (2.5 mg/dl)); 6. Unsuitable for arterial thrombolytic therapy (e.g., known history of hereditary or acquired hemorrhagic disease and/or platelet count \<50×109/L; abnormal coagulation function (INR\>1.7); oral anticoagulants were taken within 24 - 48 hours before onset within APTT \> 3 times normal; recent medical history or clinical manifestations of brain tumors other than meningiomas); 7. Any terminal disease with life expectancy \<1 year; 8. Pregnancy or lactation; 9. Concurrent participation in another investigational drug or device study that could interfere with the present trial; 10. Other circumstances that participation is not deemed appropriate.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China