Stroke, Ischemic Clinical Trial
Official title:
Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK): a Prospective, Randomized, Open-label, Blinded End Point, and Multicenter Trial
Verified date | March 2023 |
Source | General Hospital of Shenyang Military Region |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | March 15, 2025 |
Est. primary completion date | March 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | General Hospital of Northern Theater Command | ShenYang |
Lead Sponsor | Collaborator |
---|---|
General Hospital of Shenyang Military Region | Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | proportion of patients with successful Medium vessel occlusion (MeVO) recanalization | 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 | immediately after finishing intra-arterial tenecteplase | |
Secondary | proportion of modified Rankin Scale (mRS) 0-1 | mRS scores range from 0 to 6, with higher scores indicating worse outcome | Day 90 | |
Secondary | proportion of modified Rankin Scale (mRS) 0-2 | mRS scores range from 0 to 6, with higher scores indicating worse outcome | Day 90 | |
Secondary | distribution of modified Rankin Scale (mRS) | mRS scores range from 0 to 6, with higher scores indicating worse outcome | Day 90 | |
Secondary | incidence of early neurological improvement | early neurological improvement is defined as a decrease of more than 4 points or reaching 0 points in NIHSS score, compared with baseline | 24 (-6/+24) hours | |
Secondary | Changes in National Institute of Health stroke scale (NIHSS) | NIHSS scores range 0-42, with higher scores indicating greater stroke severity | 24 (-6/+24) hours | |
Secondary | rate of visual recovery in patients with posterior cerebral artery occlusion | 7 days or at hospital discharge | ||
Secondary | proportion of symptomatic intracranial hemorrhage | symptomatic intracranial hemorrhage is defined as an increase in the NIHSS score of =4 points as a result of the intracranial hemorrhage | 24 (-6/+24) hours | |
Secondary | proportion of parenchymal hematoma type 1 and 2 | 24 (-6/+24) hours | ||
Secondary | all serious adverse events | 24 (-6/+24) hours | ||
Secondary | all-cause death | 7 days | ||
Secondary | recurrent stroke, cardiovascular events, other vascular events and death | 90 days |
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