Stroke, Ischemic
Conditions
Brief summary
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.
Interventions
DRUGTenecteplase
intra-arterial tenecteplase
Sponsors
Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years; 2. 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. 3. Within 24 hours from symptom onset; 4. Signed informed consent by patient or patient's legally authorized representative.
Exclusion criteria
1. Patients with completed infarction in the territory of the MeVO on non-contrast CT; 2. Patients with intracranial hemorrhage; 3. Coagulation disorders, tendency for systemic hemorrhagic, thrombocytopenia (\<100,000/mm3); 4. 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; 5. After mechanical thrombectomy, severe and sustained (\> 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg); 6. Patients with contraindication or allergy to any ingredient of study medication; 7. Pregnancy, plan to get pregnant or active lactation; 8. The estimated life expectancy is less than 6 months due to other serious diseases; 9. Other conditions unsuitable for this clinical study as assessed by researcher.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of patients with successful Medium vessel occlusion (MeVO) recanalization | 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
| Measure | Time frame | Description |
|---|---|---|
| proportion of modified Rankin Scale (mRS) 0-1 | Day 90 | mRS scores range from 0 to 6, with higher scores indicating worse outcome |
| distribution of modified Rankin Scale (mRS) | Day 90 | mRS scores range from 0 to 6, with higher scores indicating worse outcome |
| incidence of early neurological improvement | 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 |
| Changes in National Institute of Health stroke scale (NIHSS) | 24 (-6/+24) hours | NIHSS scores range 0-42, with higher scores indicating greater stroke severity |
| rate of visual recovery in patients with posterior cerebral artery occlusion | 7 days or at hospital discharge | — |
| proportion of modified Rankin Scale (mRS) 0-2 | Day 90 | mRS scores range from 0 to 6, with higher scores indicating worse outcome |
| proportion of parenchymal hematoma type 1 and 2 | 24 (-6/+24) hours | — |
| all serious adverse events | 24 (-6/+24) hours | — |
| all-cause death | 7 days | — |
| recurrent stroke, cardiovascular events, other vascular events and death | 90 days | — |
| proportion of symptomatic intracranial hemorrhage | 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 |
Countries
China
Outcome results
None listed