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New stroke treatment aims to bust clots directly in the brain

NCT ID NCT07668323

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 306 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

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 to 80 years

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • the First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210000, China

More trials for these conditions

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