New stroke treatment aims to bust clots directly in the brain
NCT ID NCT07668323
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether giving clot-busting drugs directly into the blocked brain artery (intra-arterial thrombolysis) helps people recover better from a medium-vessel stroke. About 306 adults aged 18-80 with acute stroke will be randomly assigned to receive either the drug plus standard care or standard care alone. The main goal is to see if more people achieve functional independence (able to carry out daily activities) 90 days after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- clot-busting drugs (alteplase or tenecteplase)
- What this could lead to
- If it works, this could offer a new treatment option for people with medium-vessel stroke, potentially improving recovery and reducing disability.
- What could go wrong
- This is an early-stage trial with only 306 participants, so results may not apply to everyone. There is a risk of bleeding or other complications from the procedure.
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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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 306 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
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 to 80 years
- 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: * Age 18 to 80 years. * Time from symptom onset or last known well to randomization within 24 hours. * Clinical diagnosis of acute ischemic stroke confirmed by CTA or MRA as being caused by isolated acute medium vessel occlusion, including distal M2/M3 segments of the middle cerebral artery, A2/A3 segments of the anterior cerebral artery, or P1/P2/P3 segments of the posterior cerebral artery. Isolated occlusion is defined as a single symptomatic vessel occlusion; patients with multiple vessel occlusions or uncertain culprit vessel are excluded. * Baseline NIHSS score ≥ 6, or 3-5 with disabling deficits (e.g., motor weakness, aphasia, visual field defects), and NIHSS score ≤ 25 at the time of randomization. * For patients presenting beyond 6 hours from symptom onset: perfusion imaging criteria require Tmax \> 6s volume ≥ 10 cc, and core infarct volume (defined as rCBF \< 30%) less than 50% of the Tmax \> 6s volume. * Patient or legally authorized representative is able to understand and voluntarily sign the informed consent form. Exclusion Criteria: * Clinical Exclusion Criteria: * Pre-stroke modified Rankin Scale (mRS) score \> 2. * Presence of contraindications to intravenous thrombolysis. * Known allergy to heparin, contrast media, anesthetics, or other definite contraindications to endovascular treatment. * Comorbid severe diseases that may affect outcome assessment, including but not limited to malignancy, severe heart failure, or renal failure, with expected life expectancy \< 6 months. * Uncontrolled hypertension refractory to medical therapy (systolic blood pressure \> 220 mmHg or diastolic blood pressure \> 120 mmHg). * Baseline blood glucose \< 2.8 mmol/L (50 mg/dL) or \> 22.2 mmol/L (400 mg/dL). * Known bleeding diathesis, including but not limited to: platelet count \< 100 × 10⁹/L; heparin treatment within 48 hours with APTT ≥ 35 seconds; oral warfarin with INR \> 3. Note: Patients without a history or suspicion of coagulation disorders do not require laboratory testing for coagulation parameters prior to enrollment. * Stroke onset with seizure or seizure occurring during the course of stroke, precluding accurate determination of baseline NIHSS score. * Female patients who are pregnant, lactating, or have a positive pregnancy test at hospital admission. * Currently participating in another investigational drug or device study that may interfere with the results of this study. * Other conditions judged by the investigator to be unsuitable for participation or posing significant risk to the patient. * Imaging Exclusion Criteria: * Intracranial hemorrhage confirmed by baseline head CT or MRI, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, or subdural/epidural hemorrhage. * Presence of midline shift or cerebral herniation, or other ventricular mass effect with midline shift. * Anticipated inability to complete endovascular treatment due to vascular tortuosity, severe vessel wall calcification, or other anatomical challenges. * Aortic dissection. * Multiple vessel occlusions confirmed by CTA or MRA with inability to identify the symptomatic culprit vessel, such as bilateral middle cerebral artery occlusion or concurrent middle cerebral artery and basilar artery occlusion. * Suspected or confirmed non-acute occlusion of the symptomatic culprit vessel.
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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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the First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an earthworm enzyme boost stroke recovery?
- Can a Rapid-Acting clot blocker boost stroke recovery?
- Can Real-World data improve stroke recovery?
- Can a common antibiotic shield the brain after a stroke?
- Can a simple relaxation technique soothe the mind after a stroke?