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

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: Not yet recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Other: Standard medical treatment; Procedure: Intra-arterial thrombolysis

• Study Type: Interventional
• Enrollment (Estimated): 488
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xianhua Hou; Phone Number: 86-13594020663; Email: houxianhua@tmmu.edu.cn
• Study Contact Backup: Name: Lin Chen; Phone Number: 86-18602300737; Email: 406019975@qq.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1	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

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2	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)	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	All-cause mortality at 90 days	up to 90 days
Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH)	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	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	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

• Sponsor: Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID 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