Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO)

March 18, 2026 updated by: Zhenhua Zhou, Southwest Hospital, China

Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO): A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Clinical Trial

DATE-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of tenecteplase combined with standard medications in acute ischemic stroke patients with medium vessel occlusion stroke within 24 hours of onset.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
488

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Ankang, China
        • Ankang Central Hospital
        • Contact:
          • Chu Xingjv
          • Phone Number: +86 15319843133
      • Anyang, China
        • The People's Hospital of Anyang City
        • Contact:
          • Zhang Jiangang
      • Changchun, China
        • Changchun Central Hospital
        • Contact:
          • Wang Lesheng
          • Phone Number: +86 13596227220
      • Chengdu, China
        • Chengdu Second People's Hospital
        • Contact:
          • Wu Changchuan
          • Phone Number: +86 15388151282
      • Chongqing, China
        • The Ninth People'S Hospital of Chongqing
        • Contact:
          • Huang Shuchun
          • Phone Number: +86 18708533468
      • Chongqing, China
        • Chongqing University Fuling Hospital
      • Chongqing, China
        • Yunyang County People's Hospital
        • Contact:
          • Cai Tieying
          • Phone Number: +86 13896311415
      • Chongqing, China
        • Chonggang General Hospital
        • Contact:
          • Ding Chawen
          • Phone Number: +86 17764830950
      • Chongqing, China
        • Jiangjin Central Hospital
        • Contact:
          • Zhang Zuowen
          • Phone Number: +86 15823472901
      • Chongqing, China
        • The Thrid Affiliated Hospital of CQMU
        • Contact:
          • Cheng Saiyu
          • Phone Number: +86 13527598096
      • Fuzhou, China
        • The First Affiliated Hospital of Fujian Medicaluniversity
        • Contact:
          • Zhao Wenlong
          • Phone Number: +86 18060893376
      • Guangyuan, China
        • Guangyuan Central Hospital
        • Contact:
          • Pu Tianqiang
          • Phone Number: +86 18227306608
      • Guizhou, China
        • Qiandongnan Prefecture People's Hospital
        • Contact:
          • Shen Jian
          • Phone Number: +86 15985527337
      • Huaibei, China
        • Huaibei Miners General Hospital
        • Contact:
          • Ma Xinan
          • Phone Number: +86 15805619166
      • Jianyang, China
        • The People's Hospital Of Jianyang City
        • Contact:
          • Tang Jie
          • Phone Number: +86 15123825598
      • Jinan, China
        • The 960th Hospital of the PLA Joint Logistics Support Force
      • Luoyang, China
        • The First Affiliated Hospital of Henan University of Science And Technology
        • Contact:
          • Shen Ruile
          • Phone Number: +86 15703790088
      • Luoyang, China
        • Luoyang Mengjin People's Hospital
        • Contact:
          • Zhao Haojin
          • Phone Number: +86 18937982836
      • Luoyang, China
        • Yiyang County People'S Hospital
        • Contact:
          • Zhao Jingjing
          • Phone Number: +86 18103797861
      • Luzhou, China
        • The Affiliated Hospital of Southwest Medical University
        • Contact:
          • Yuan Zhengzhou
          • Phone Number: +86 18111209050
      • Luzhou, China
        • The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University
        • Contact:
          • Guo Zhaoyun
          • Phone Number: +86 13440011005
      • Mianyang, China
        • Mianyang 404 Hospital
        • Contact:
          • Luo Jun
          • Phone Number: +86 13518319060
      • Mudanjiang, China
        • Mudanjiang First People's Hospital
        • Contact:
          • Yu Pengfei
          • Phone Number: +86 13604609208
      • Qingzhen, China
        • The First People's Hospital of Qingzhen
        • Contact:
          • Fu Hang
          • Phone Number: +86 15338501820
      • Sanmenxia, China
        • Yellow River Sanmenxia Hospital
        • Contact:
          • Wu Xiaofeng
          • Phone Number: +86 13639893979
      • Shangqiu, China
        • The First People's Hospital of Shangqiu
      • Shangqiu, China
        • Ninglin People's Hospital
        • Contact:
          • Ju Zhixiang
      • Suining, China
        • The People's Hospital Of An Jv
        • Contact:
          • Liao Jiasheng
          • Phone Number: +86 18398444888
      • Tangshan, China
        • Yutian Hospital
        • Contact:
          • Li Haijun
          • Phone Number: +86 13111464171
      • Wuhan, China
        • Zhongnan Hospital of Wuhan University
        • Contact:
          • Mei Bin
          • Phone Number: +86 13037196699
      • Wuhan, China
        • Wuhan Puren Hospital
      • Xiangyang, China
        • Xiangyang No.1 People's hospital
        • Contact:
          • Zhou Peiyang
          • Phone Number: +86 13597491119
      • Ya'an, China
        • Yaan People's Hospital
        • Contact:
          • Wang Jian
          • Phone Number: +86 13550064528
      • Yichang, China
        • Yichang Central People's Hospital
        • Contact:
          • Zhou Jinghua
          • Phone Number: +86 15971663190
      • Zhengzhou, China
        • Zhengzhou Central Hospital
        • Contact:
          • Zhou You
          • Phone Number: +86 15713891958
      • Zhoukou, China
        • Zhoukou Central hospital
        • Contact:
          • Li Shuai
          • Phone Number: +86 18595389709
      • Zhumadian, China
        • Zhumadian Central Hospital
      • Zhuzhou, China
        • ZhuZhou Central Hospital
      • Zigong, China
        • Zigong Third People's Hospital
    • Guangxi
      • Baise City, Guangxi, China
        • Affiliated Hospital of Youjiang Medical University for Nationalities
      • Guilin, Guangxi, China
        • Guilin People'S Hospital
        • Contact:
          • Pan Honghua
          • Phone Number: +86 18978337949
    • Guizhou
      • Qiannan, Guizhou, China
        • The People's Hospital Of QianNan
        • Contact:
          • Jiang Maojun
          • Phone Number: +86 15185516184
    • Sichuan
      • Chengdu, Sichuan, China
        • Chongzhou People's Hospital
        • Contact:
          • Wu Youlin
          • Phone Number: +86 18628172896
    • Yunnan
      • Dali, Yunnan, China
        • Dali Nationality Autonomous Prefecture Hospital
        • Contact:
          • Han Shibo
          • Phone Number: +86 18908722303
      • Qujing, Yunnan, China
        • Qujing Central Hospital of Yunnan Province
        • Contact:
          • Chen Boyu
          • Phone Number: +86 18064858755

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TNK intra-arterial thrombolysis group
Intra-arterial thrombolysis
Procedure: Intra-arterial thrombolysis
A standardized microcatheter-based technique was used to administer recombinant TNK-tPA directly into the thrombus. The total dose (0.0625 mg/kg, max 6.25 mg) was delivered in three equal parts: distally, within the mid-clot, and proximally. Angiographic reassessment at 5 minutes determined if a second identical dose was required (max cumulative dose: 0.125 mg/kg). The procedure was continuously monitored and could be terminated immediately for safety concerns.
Active Comparator: Standard medical therapy group
Only standard medical therapy
Other: Standard medical treatment
Standard medical treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1
Time Frame: At Day 90±7 days
Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).
At Day 90±7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2
Time Frame: At Day 90±7 days
Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).
At Day 90±7 days
Distribution of Modified Rankin Scale (mRS)
Time Frame: At Day 90±7 days
Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).
At Day 90±7 days
All-cause mortality
Time Frame: up to 90 days
All-cause mortality at 90 days
up to 90 days
Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH)
Time Frame: up to 48 hours
sICH via criteria adapted from the European Cooperative Acute Stroke Study (ECASS III), defined as any apparent extravascular blood in the brain or within the cranium that is associated with clinical deterioration defined by an NIHSS score increase of four points or more from baseline.
up to 48 hours
Improvement in NIHSS between baseline and 5-7 days
Time Frame: at 5-7 days from randomization
National Institutes of Health Stroke Scale (NIHSS) is a 11-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 6 grades with 0 as normal, and there is an allowance for untestable items.Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits
at 5-7 days from randomization
EQ-5D-5L score
Time Frame: At Day 90±7 days
Health-related quality of life (the score on the EuroQol Group 5-Dimension 5-Level [EQ-5D-5L] questionnaire, range,-0.39 to 1, with higher scores indicating better quality of life)
At Day 90±7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Southwest Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025.8.10V1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.

IPD Sharing Time Frame

6 months after the trial completion.

IPD Sharing Access Criteria

The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Ischemic Stroke

Clinical Trials on Standard medical treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings