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Completed

NCT Number: NCT05657470

Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)

The best reperfusion strategy for medium-sized vessel occlusion (MeVO) is not well established. Given the proven treatment effect of intra-arterial thrombolysis in patients with large vessel occlusion (LVO), the investigators hypothesized that intra-arterial tenecteplase (TNK) could increase the recanalization rate of MeVO and thus improve clinical outcome. The current study aimed to explore the safety and efficacy of intra-arterial TNK in patients with MeVO.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

General Hospital of Northern Theater Command

Shenyang, 110840, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years;
  • Medium vessel occlusion (MeVO), referring to M2-3 of MCA; A1-3 of ACA; P1-3 of PCA; PICA, AICA or SCA (including primary, distal embolism in the same region after thrombectomy or concurrent embolism in other regions).
  • Primary MeVO as detected by the first DSA examination or secondary MeVO after mechanical thrombectomy for large vessel occlusion;
  • MeVO causes neurological deficits in motor strength, language, vision etc;
  • Endovascular mechanical thrombectomy cannot be performed as assessed by the investigator;
  • Absence of parenchymal hematoma on CT images performed in the angio suite.
  • Within 24 hours from symptom onset;
  • Signed informed consent by patient or patient's legally authorized representative.

Exclusion criteria

  • Patients with completed infarction in the territory of the MeVO on non-contrast CT;
  • Patients with intracranial hemorrhage;
  • Coagulation disorders, tendency for systemic hemorrhagic, thrombocytopenia (<100,000/mm3);
  • Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
  • After mechanical thrombectomy, severe and sustained (> 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg);
  • Patients with contraindication or allergy to any ingredient of study medication;
  • Pregnancy, plan to get pregnant or active lactation;
  • The estimated life expectancy is less than 6 months due to other serious diseases;
  • Other conditions unsuitable for this clinical study as assessed by researcher.

Treatment and study plan

Tenecteplase

Drug

intra-arterial tenecteplase

Primary outcomes

  1. proportion of patients with successful Medium vessel occlusion (MeVO) recanalization

    Time frame: immediately after finishing intra-arterial tenecteplase

    successful MeVO recanalization is defined as the expanded treatment in cerebral ischemia (eTICI) score 2b67-3 in the territory of the target occluded MeVO artery

Secondary outcomes

  1. proportion of modified Rankin Scale (mRS) 0-1

    Time frame: Day 90

    mRS scores range from 0 to 6, with higher scores indicating worse outcome

  2. proportion of modified Rankin Scale (mRS) 0-2

    Time frame: Day 90

    mRS scores range from 0 to 6, with higher scores indicating worse outcome

  3. distribution of modified Rankin Scale (mRS)

    Time frame: Day 90

    mRS scores range from 0 to 6, with higher scores indicating worse outcome

  4. incidence of early neurological improvement

    Time frame: 24 (-6/+24) hours

    early neurological improvement is defined as a decrease of more than 4 points or reaching 0 points in NIHSS score, compared with baseline

  5. Changes in National Institute of Health stroke scale (NIHSS)

    Time frame: 24 (-6/+24) hours

    NIHSS scores range 0-42, with higher scores indicating greater stroke severity

  6. rate of visual recovery in patients with posterior cerebral artery occlusion

    Time frame: 7 days or at hospital discharge

  7. proportion of symptomatic intracranial hemorrhage

    Time frame: 24 (-6/+24) hours

    symptomatic intracranial hemorrhage is defined as an increase in the NIHSS score of ≥4 points as a result of the intracranial hemorrhage

  8. proportion of parenchymal hematoma type 1 and 2

    Time frame: 24 (-6/+24) hours

  9. all serious adverse events

    Time frame: 24 (-6/+24) hours

  10. all-cause death

    Time frame: 7 days

  11. recurrent stroke, cardiovascular events, other vascular events and death

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Collaborators

  • Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning

Registry information

Official study title

Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK): a Prospective, Randomized, Open-label, Blinded End Point, and Multicenter Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2022
Registry last updated
Jun 17, 2025

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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