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NCT Number: NCT07469293

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Affiliated Hospital of Youjiang Medical University for Nationalities, Baise City, Guangxi, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intra-arterial Thrombolysis

Procedure

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.

Standard Medical Treatment

Other

Standard medical treatment

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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

  3. 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).

  4. 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).

  5. 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)

  6. All-cause mortality

    Time frame: up to 90 days

    All-cause mortality at 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Southwest Hospital, China

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 13, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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