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

Official title

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

Overview

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.

Interventions

• 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.
• Other Standard medical treatment
  Standard medical treatment

Primary outcome measures

• Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1 [Time frame: At Day 90±7 days]

Secondary outcome measures (6)

• Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH) [Time frame: up to 48 hours]
• Improvement in NIHSS between baseline and 5-7 days [Time frame: at 5-7 days from randomization]
• Distribution of Modified Rankin Scale (mRS) [Time frame: At Day 90±7 days]
• Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2 [Time frame: At Day 90±7 days]
• EQ-5D-5L score [Time frame: At Day 90±7 days]
• All-cause mortality [Time frame: up to 90 days]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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;
• Occlusions in multiple vascular territories confirmed by CTA/MRA;
• Other reasons that the investigator deems inappropriate for participation in the trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 45 centers

• Affiliated Hospital of Youjiang Medical University for Nationalities — Baise City
• Guilin People'S Hospital — Guilin
• The People's Hospital Of QianNan — Qiannan
• Chongzhou People's Hospital — Chengdu
• Dali Nationality Autonomous Prefecture Hospital — Dali
• Qujing Central Hospital of Yunnan Province — Qujing
• Ankang Central Hospital — Ankang
• The People'S Hospital of Anyang City — Anyang
• … and 37 more centers

Identifiers

NCT: NCT07469293 · 2025.8.10V1.0

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗