Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)

• Status: Not yet recruiting
• Trial end date: 2025-02-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: General Hospital of Shenyang Military Region
• Collaborator: Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning
• Treatments: Tenecteplase

Criteria

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.