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NCT Number: NCT07357987

Intra-arterial Tenecteplase for Acute Medium Vessel Occlusion Stroke

The ANGEL-MeVO-TNK is a multicentered, prospective, randomized, open label, blinded endpoint (PROBE) phase III trial. A total of 488 AIS patients (age ≥18 years) with acute MeVO-AIS (occlusion of the M2/M3, the A1/A2/A3, the P1/P2/P3, and with baseline NIHSS score >5 or disabling stroke with NIHSS score 3-5 [such as neurological deficits in motor strength, language, vision, etc]), will be enrolled. Patients fulfilling all the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into the IA TNK group or the control group after offering informed content.

* The IA TNK group：1) If the patient has not received IVT, IA TNK will be administered as a slow, continuous infusion for super-selective contact thrombolysis in a stepwise manner: an initial dose of 0.0625 mg/kg with a duration of 15 minutes. A repeat angiographic assessment will then be performed; if recanalization is not achieved, an additional dose of 0.0625 mg/kg will be administered over a further 15 minutes (maximum dose 12.5 mg) .

2) If the patient has received IVT, intra-arterial TNK will be administered as a slow infusion for super-selective contact thrombolysis at a dose of 0.0625 mg/kg (maximum dose 6.25 mg) with a duration of 15 minutes. * The control group will be given standard medical management.

The study consists of four visits including the day of randomization, 48±12 hours after randomization, and 90±7 days after randomization. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program.

The primary outcome is the modified Rankin Scale (mRS) score of 0 to 1 at 90±7 days after onset. The primary safety outcome is the incidence of sICH within 48±12 hours after randomization (ECASS III).

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Endovascular Treatment Medium Vessel Occlusion Nervous System Diseases Stroke Tenecteplase Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Liping Liu

CONTACT

[email protected]

86-010-59978328

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Clinical Inclusion Criteria:

  • Age ≥18 years;
  • Pre-stroke mRS 0-1;
  • Within 24 h from symptom onset;
  • Baseline National Institutes of Health Stroke Scale (NIHSS) score >5 or baseline NIHSS 3-5 with disabling deficit (e.g., loss of hand function, aphasia, hemianopia);
  • Informed consent obtained from patients or their legal representatives.

Imaging Inclusion Criteria:

  • Baseline CTA/MRA/DSA diagnosed isolated MeVO, referring to the M2/M3 segment of the MCA, the A1/A2/A3 segment of the ACA, the P1/P2/P3 segment of the PCA;
  • NCCT or MRI DWI imaging showing that the territory of the ischemic infarct volume is less than 50% of the estimated territory supplied by the occluded artery.

Exclusion criteria

  • Acute intracranial hemorrhage;
  • ASPECT ≤5;
  • MeVO secondary to spontaneous fragmentation and distal migration of thrombus from an acute large vessel occlusion, or occurring after intravenous thrombolysis (IVT), intra-arterial thrombolysis, or endovascular thrombectomy;
  • Contraindication to TNK;
  • Known severe allergy to contrast agents (excluding mild rash-type allergic reactions);
  • Use of heparin or novel oral anticoagulants within the previous 48 hours with an INR ≥ 1.7;
  • A history of major bleeding within the past 6 months or the presence of conditions such as active gastrointestinal ulcer, aortic dissection, platelet count < 100 × 10⁹/L, etc.;
  • Radiologically confirmed vascular malformations, arterial dissection, intracranial aneurysm (diameter≥3 mm), tumors (except small meningiomas), cerebral vasculitis, cerebral amyloid angiopathy, or other major non-ischemic intracranial diseases (e.g., multiple sclerosis);
  • Acute renal failure, current dialysis, or estimated glomerular filtration rate (eGFR)<30ml/min/1.72m2, and/or serum creatinine>220mmol/L (2.5mg/dl);
  • History of severe liver disease, or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or glutamyl transferase (GGT) ≥3×upper limit of normal value (ULN) and/or total bilirubin (TBIL) ≥2×ULN;
  • Severe non-cardiovascular comorbidity with an expected life expectancy of less than 3 months (e.g., malignant tumors);
  • Known pregnancy or breastfeeding, or a positive pregnancy test prior to randomization;
  • Current participation in another drug or device clinical trial;
  • Any other condition deemed by the investigator to make the patient unsuitable for participation in the study or to pose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric illness, cognitive impairment, or emotional disorders).

Treatment and study plan

Intra-arterial Tenecteplase

Procedure
  • If the patient has not received IVT, IA TNK will be administered as a slow, continuous infusion for super-selective contact thrombolysis in a stepwise manner: an initial dose of 0.0625 mg/kg with a duration of 15 minutes. A repeat angiographic assessment will then be performed; if recanalization is not achieved, an additional dose of 0.0625 mg/kg will be administered over a further 15 minutes (maximum dose 12.5 mg) .
  • If the patient has received IVT, intra-arterial TNK will be administered as a slow infusion for super-selective contact thrombolysis at a dose of 0.0625 mg/kg (maximum dose 6.25 mg) with a duration of 15 minutes.

Standard medical management

Drug

Patients will receive standard medical management as recommended by current guidelines#

#《Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2023)》and《Chinese Guidelines for Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack (2022)》

Primary outcomes

  1. mRS score of 0 to 1 at 90±7 days after onset

    Time frame: 90±7 days after onset

    The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death), with 0 indicating no symptoms at all; 1 indicating no significant disability despite symptoms: able to carry out all usual duties and activities, 2 indicating slight disability: unable to carry out all previous activities but able to look after own affairs without assistance; 3 indicating moderate disability: requiring some help, but able to walk without assistance; 4 indicating moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance; 5 indicating severe disability: bedridden, incontinent, and requiring constant nursing care and attention; and 6 indicating death.

  2. symptomatic intracerebral hemorrhage within 48±12 hours after randomization

    Time frame: 48±12 hours after randomization

    symptomatic intracerebral hemorrhage (sICH) within 48±12 hours after randomization (ECASS III criteria)

Secondary outcomes

  1. Ordinal mRS score at 90±7 days after onset

    Time frame: 90±7 days after onset

    The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death), with 0 indicating no symptoms at all; 1 indicating no significant disability despite symptoms: able to carry out all usual duties and activities, 2 indicating slight disability: unable to carry out all previous activities but able to look after own affairs without assistance; 3 indicating moderate disability: requiring some help, but able to walk without assistance; 4 indicating moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance; 5 indicating severe disability: bedridden, incontinent, and requiring constant nursing care and attention; and 6 indicating death.

  2. mRS score 0 to 2 at 90±7 days after onset

    Time frame: 90±7 days after onset

    The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death), with 0 indicating no symptoms at all; 1 indicating no significant disability despite symptoms: able to carry out all usual duties and activities, 2 indicating slight disability: unable to carry out all previous activities but able to look after own affairs without assistance; 3 indicating moderate disability: requiring some help, but able to walk without assistance; 4 indicating moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance; 5 indicating severe disability: bedridden, incontinent, and requiring constant nursing care and attention; and 6 indicating death.

  3. mRS score 0 to 3 at 90±7 days after onset

    Time frame: 90±7 days after onset

    The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death), with 0 indicating no symptoms at all; 1 indicating no significant disability despite symptoms: able to carry out all usual duties and activities, 2 indicating slight disability: unable to carry out all previous activities but able to look after own affairs without assistance; 3 indicating moderate disability: requiring some help, but able to walk without assistance; 4 indicating moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance; 5 indicating severe disability: bedridden, incontinent, and requiring constant nursing care and attention; and 6 indicating death.

  4. Number of Participants with Recanalization of the target occluded artery within 48 ± 12 hours after randomization

    Time frame: 48 ± 12 hours after randomization

    defined as an Arterial Occlusive Lesion [AOL] score of 2-3 on CTA or MRA. The Arterial Occlusive Lesion (AOL) Score is a standardized, angiographic (imaging-based) classification system used to quantify the degree of recanalization (blood flow restoration) in an occluded artery following an endovascular thrombectomy procedure for acute ischemic stroke. Score Range: 0 to 3 (ordinal). A higher score indicates a greater degree of successful mechanical recanalization of the target artery.

  5. Infarct volume at 48 ± 12 hours after randomization

    Time frame: 48 ± 12 hours after randomization

    Infarct volume at 48 ± 12 hours after randomization (assessed by NCCT or MRI DWI)

  6. Change in NIHSS between baseline and 24±2 hours after randomization

    Time frame: 24±2 hours after randomization

    The National Institutes of Health Stroke Scale (NIHSS) is a standardized, quantitative assessment tool used by healthcare providers to objectively evaluate and quantify the neurological deficit and severity of impairment in patients with acute ischemic stroke. Total Score Range: 0 to 42. A higher total score indicates greater neurological impairment.

  7. Number of Participants with Any ICH within 48±12 hours after randomization

    Time frame: 48±12 hours after randomization

    Any ICH within 48±12 hours after randomization

  8. Mortality within 90±7 days after onset

    Time frame: 90±7 days after onset

    Mortality within 90±7 days after onset

Study contacts

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

Liping Liu

CONTACT

[email protected]

+86-010-59978328

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

Intra-arterial Tenecteplase for Acute Medium Vessel Occlusion Stroke: the ANGEL-MeVO-TNK Randomized Clinical Trial

Acronym: ANGEL-MeVO-TNK

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2026
Registry last updated
Apr 30, 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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