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New stroke treatment could help patients with medium clots

NCT ID NCT07469293

Disease control Sponsor: Southwest Hospital, China Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether giving the drug tenecteplase directly into the brain's arteries, along with standard care, helps people recover better after a stroke caused by a medium-sized blood clot. About 488 adults with stroke symptoms starting within 24 hours will take part. The goal is to see if this approach reduces disability without increasing dangerous bleeding.

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 488 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 100 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: 1. Age ≥18 years old 2. Acute isolated intracranial medium vessel occlusion (Distal middle cerebral artery M2; M3 and M4 segments of the middle cerebral artery; A1-A4 segments of the anterior cerebral artery; P1-P3 segments of the posterior cerebral artery), confirmed by imaging, with symptom onset to randomization within 24 hours; 3. NlHSS score ≥ 5 4. CT scan performed within 24 hours confirming that the ischemic lesion does not involve more than one-third of the territory supplied by the responsible vessel (no evidence of early large infarction) 5. Patients with premorbid mRS 0 or 1 6. Written informed consent obtained from the participant or a legally authorized representative Exclusion Criteria: 1. Intracranial hemorrhage confirmed by cranial CT or MRI; 2. Already received intravenous thrombolysis; 3. Planned mechanical thrombectomy; 4. Intraoperative DSA showing vessel rupture, dissection, or contrast agent extravasation; 5. Pregnant or breastfeeding women; 6. Allergy to contrast agents or tenecteplase; 7. Systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg, and failure to control with oral antihypertensive medications; 8. Genetic or acquired bleeding disorders, coagulation factor deficiencies; coagulation dysfunction, INR \> 1.7, or use of novel oral anticoagulants within 48 hours; 9. Blood glucose \< 2.8 mmol/L (50 mg/dL) or \> 22.2 mmol/L (400 mg/dL), platelet count \< 100 × 10\^9/L; 10. History of bleeding within the past month (gastrointestinal or urinary tract bleeding); 11. Chronic hemodialysis or severe renal insufficiency (glomerular filtration rate \< 30 mL/min or serum creatinine \> 220 μmol/L (2.5 mg/dL)); 12. Severe mental disorders or inability to provide informed consent and comply with follow-up due to dementia; 13. Concurrent malignant tumors or severe systemic diseases with an expected survival time of less than 90 days; 14. Intracranial aneurysms or arteriovenous malformations; 15. Participation in another clinical interventional trial within 30 days prior to randomization or currently participating in another clinical interventional trial; 16. Occlusions in multiple vascular territories confirmed by CTA/MRA; 17. Other reasons that the investigator deems inappropriate for participation in the trial

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    45 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

  • Affiliated Hospital of Youjiang Medical University for Nationalities

    Baise City, Guangxi, China

  • Ankang Central Hospital

    Ankang, China

  • Changchun Central Hospital

    Changchun, China

  • Chengdu Second People's Hospital

    Chengdu, China

  • Chonggang General Hospital

    Chongqing, China

  • Chongqing University Fuling Hospital

    Chongqing, China

  • Chongzhou People's Hospital

    Chengdu, Sichuan, China

  • Dali Nationality Autonomous Prefecture Hospital

    Dali, Yunnan, China

  • Guangyuan Central Hospital

    Guangyuan, China

  • Guilin People'S Hospital

    Guilin, Guangxi, China

  • Huaibei Miners General Hospital

    Huaibei, China

  • Jiangjin Central Hospital

    Chongqing, China

  • Luoyang Mengjin People's Hospital

    Luoyang, China

  • Mianyang 404 Hospital

    Mianyang, China

  • Mudanjiang First People's Hospital

    Mudanjiang, China

  • Ninglin People's Hospital

    Shangqiu, China

  • Qiandongnan Prefecture People's Hospital

    Guizhou, China

  • Qujing Central Hospital of Yunnan Province

    Qujing, Yunnan, China

  • The 960th Hospital of the PLA Joint Logistics Support Force

    Jinan, China

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, China

  • The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University

    Luzhou, China

  • The First Affiliated Hospital of Fujian Medicaluniversity

    Fuzhou, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, China

  • The First People'S Hospital of Shangqiu

    Shangqiu, China

  • The First People's Hospital of Qingzhen

    Qingzhen, China

  • The Ninth People'S Hospital of Chongqing

    Chongqing, China

  • The People'S Hospital of Anyang City

    Anyang, China

  • The People's Hospital Of An Jv

    Suining, China

  • The People's Hospital Of QianNan

    Qiannan, Guizhou, China

  • The People's Hospital of Jianyang City

    Jianyang, China

  • The Thrid Affiliated Hospital of CQMU

    Chongqing, China

  • Wuhan Puren Hospital

    Wuhan, China

  • Xiangyang No.1 People's Hospital

    Xiangyang, China

  • Yaan People's Hospital

    Ya'an, China

  • Yellow River Sanmenxia Hospital

    Sanmenxia, China

  • Yichang Central People's Hospital

    Yichang, China

  • Yiyang County People'S Hospital

    Luoyang, China

  • Yunyang County People'S Hospital

    Chongqing, China

  • Yutian Hospital

    Tangshan, China

  • Zhengzhou Central Hospital

    Zhengzhou, China

  • Zhongnan Hospital of Wuhan University

    Wuhan, China

  • Zhoukou Central Hospital

    Zhoukou, China

  • Zhumadian Central Hospital

    Zhumadian, China

  • Zhuzhou Central Hospital

    Zhuzhou, China

  • Zigong Third People's Hospital

    Zigong, China

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Other studies related to the condition(s) this trial covers.