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New hope for medium vessel stroke? trial tests direct Clot-Busting drug

NCT ID NCT07185022

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study is testing whether giving a clot-busting drug (tenecteplase) directly into the blocked brain artery can improve outcomes for people having a stroke caused by a medium-sized vessel blockage. About 282 participants will be randomly assigned to receive either the intra-arterial drug or standard medical care. The main goal is to see if more people achieve a good recovery (little or no disability) 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
Tenecteplase (clot-busting drug given directly into the brain artery)
What this could lead to
If it works, this could provide a new treatment option for strokes caused by medium-sized artery blockages, potentially improving recovery and reducing disability.
What could go wrong
This is an early-stage trial with only 282 participants, so results may not apply to all stroke patients. The procedure carries risks like bleeding in the brain, and previous similar studies have not shown clear benefit.

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

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

About 282 people

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

Started

Jan 2026

Expected to finish

May 2030

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

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 years * Primary medium vessel occlusion (MeVO) or severe stenosis (≥70%) was detected on CTA, MRA, or DSA, involving arterial segments including M2-M3 of the middle cerebral artery (MCA), A1-A2 of the anterior cerebral artery (ACA), P1-P2 of the posterior cerebral artery (PCA), and the anterior inferior cerebellar artery (AICA), posterior inferior cerebellar artery (PICA), and superior cerebellar artery (SCA) * The clinical symptoms were consistent with MeVO, with a NIHSS score 5 - 25, or an NIHSS score of 3-4 in the presence of disabling neurological deficits (e.g., hemianopia, aphasia, or motor dysfunction) * Intra-arterial thrombolysis was administered within the following time windows: 1. Acute ischemic stroke within 24 hours of symptom onset or last known well, including stroke with known onset, wake-up stroke and stroke with unknown onset, with no obvious hypodensity on CT and good collateral circulation on CTA; 2. Acute ischemic stroke within 24-72 hours of onset, meeting at least one of the following imaging criteria: a.CT or MR perfusion imaging demonstrating target mismatch, defined as an ischemic core volume \<30 mL, a mismatch ratio ≥1.2, and a mismatch volume ≥10 mL.; b.MRI demonstrating DWI-FLAIR mismatch, defined as the presence of acute ischemic lesions on diffusion-weighted imaging (DWI) with no corresponding hyperintense signal on FLAIR, or with FLAIR hyperintense lesions occupying less than one-third of the DWI lesion volume. * Signed informed consent obtained Exclusion Criteria: * Pre-stroke mRS ≥ 2 * Secondary MeVO or severe stenosis caused by endovascular therapy * Neuroimaging demonstrated intracranial hemorrhage, subarachnoid hemorrhage, or other hemorrhagic disorders * Non-contrast CT demonstrating a clearly hypodense lesion corresponding to the vascular territory * Platelet count \<100 × 10⁹/L, known bleeding tendency or coagulation factor deficiency, or oral anticoagulant therapy with an international normalized ratio (INR) \>3.0 * Persistent and uncontrolled hypertension, defined as systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg * History of intracranial hemorrhage within the past 3 months, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hemorrhage, or subdural hemorrhage * Presence of arteriovenous malformations or brain tumors with mass effect * Gastrointestinal or urinary tract bleeding, or major surgery within the past 3 months * Chronic dialysis or severe renal impairment, defined as a glomerular filtration rate (GFR) \<30 mL/min or serum creatinine \>220 μmol/L (2.5 mg/dL) * Patients with known allergy to thrombolytic agents or their excipients * Patients with known allergy to iodinated contrast agents or other established contraindications * Pregnant or current breastfeeding * Presence of severe systemic comorbidities with a life expectancy of less than 3 months * Deemed unsuitable for participation by the investigator for any reason

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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

    6 sites. 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

  • Fu Yang People's Hospital

    RECRUITING

    Fuyang, Anhui, China

  • Lin Quan People's Hospital

    RECRUITING

    Fuyang, Anhui, China

  • Lishui Central Hospital

    RECRUITING

    Lishui, Zhejiang, China

  • LiuZhou Worker's Hospital

    RECRUITING

    Liuzhou, Guangxi, China

  • Shucheng People's Hospital

    RECRUITING

    Lu'an, Anhui, China

  • The Second (Affiliated) Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230031, China

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