Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO)
1 other identifier
interventional
488
1 country
45
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2026
Typical duration for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2026
CompletedFirst Posted
Study publicly available on registry
March 13, 2026
CompletedStudy Start
First participant enrolled
March 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
March 20, 2026
March 1, 2026
2.8 years
February 9, 2026
March 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH)
up to 48 hours
Improvement in NIHSS between baseline and 5-7 days
at 5-7 days from randomization
Distribution of Modified Rankin Scale (mRS)
At Day 90±7 days
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2
At Day 90±7 days
EQ-5D-5L score
At Day 90±7 days
- +1 more secondary outcomes
Study Arms (2)
TNK intra-arterial thrombolysis group
EXPERIMENTALIntra-arterial thrombolysis
Standard medical therapy group
ACTIVE COMPARATOROnly standard medical therapy
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age ≥18 years old
- 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;
- NlHSS score ≥ 5
- 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)
- Patients with premorbid mRS 0 or 1
- Written informed consent obtained from the participant or a legally authorized representative
You may not qualify if:
- Intracranial hemorrhage confirmed by cranial CT or MRI;
- Already received intravenous thrombolysis;
- Planned mechanical thrombectomy;
- Intraoperative DSA showing vessel rupture, dissection, or contrast agent extravasation;
- Pregnant or breastfeeding women;
- Allergy to contrast agents or tenecteplase;
- Systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg, and failure to control with oral antihypertensive medications;
- Genetic or acquired bleeding disorders, coagulation factor deficiencies; coagulation dysfunction, INR \> 1.7, or use of novel oral anticoagulants within 48 hours;
- Blood glucose \< 2.8 mmol/L (50 mg/dL) or \> 22.2 mmol/L (400 mg/dL), platelet count \< 100 × 10\^9/L;
- History of bleeding within the past month (gastrointestinal or urinary tract bleeding);
- Chronic hemodialysis or severe renal insufficiency (glomerular filtration rate \< 30 mL/min or serum creatinine \> 220 μmol/L (2.5 mg/dL));
- Severe mental disorders or inability to provide informed consent and comply with follow-up due to dementia;
- Concurrent malignant tumors or severe systemic diseases with an expected survival time of less than 90 days;
- Intracranial aneurysms or arteriovenous malformations;
- Participation in another clinical interventional trial within 30 days prior to randomization or currently participating in another clinical interventional trial;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Affiliated Hospital of Youjiang Medical University for Nationalities
Baise City, Guangxi, China
Guilin People'S Hospital
Guilin, Guangxi, China
The People's Hospital Of QianNan
Qiannan, Guizhou, China
Chongzhou People's Hospital
Chengdu, Sichuan, China
Dali Nationality Autonomous Prefecture Hospital
Dali, Yunnan, China
Qujing Central Hospital of Yunnan Province
Qujing, Yunnan, China
Ankang Central Hospital
Ankang, China
The People'S Hospital of Anyang City
Anyang, China
Changchun Central Hospital
Changchun, China
Chengdu Second People's Hospital
Chengdu, China
Chonggang General Hospital
Chongqing, China
Chongqing University Fuling Hospital
Chongqing, China
Jiangjin Central Hospital
Chongqing, China
The Ninth People'S Hospital of Chongqing
Chongqing, China
The Thrid Affiliated Hospital of CQMU
Chongqing, China
Yunyang County People'S Hospital
Chongqing, China
The First Affiliated Hospital of Fujian Medicaluniversity
Fuzhou, China
Guangyuan Central Hospital
Guangyuan, China
Qiandongnan Prefecture People's Hospital
Guizhou, China
Huaibei Miners General Hospital
Huaibei, China
The People's Hospital of Jianyang City
Jianyang, China
The 960th Hospital of the PLA Joint Logistics Support Force
Jinan, China
Luoyang Mengjin People's Hospital
Luoyang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
Yiyang County People'S Hospital
Luoyang, China
The Affiliated Hospital of Southwest Medical University
Luzhou, China
The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University
Luzhou, China
Mianyang 404 Hospital
Mianyang, China
Mudanjiang First People's Hospital
Mudanjiang, China
The First People's Hospital of Qingzhen
Qingzhen, China
Yellow River Sanmenxia Hospital
Sanmenxia, China
Ninglin People's Hospital
Shangqiu, China
The First People'S Hospital of Shangqiu
Shangqiu, China
The People's Hospital Of An Jv
Suining, China
Yutian Hospital
Tangshan, China
Wuhan Puren Hospital
Wuhan, China
Zhongnan Hospital of Wuhan University
Wuhan, China
Xiangyang No.1 People's Hospital
Xiangyang, China
Yaan People's Hospital
Ya'an, China
Yichang Central People's Hospital
Yichang, China
Zhengzhou Central Hospital
Zhengzhou, China
Zhoukou Central Hospital
Zhoukou, China
Zhumadian Central Hospital
Zhumadian, China
Zhuzhou Central Hospital
Zhuzhou, China
Zigong Third People's Hospital
Zigong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 9, 2026
First Posted
March 13, 2026
Study Start
March 25, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 6 months after the trial completion.
- Access Criteria
- The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.
The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.