Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status and phase: Completed; Phase 3; Phase 2

Conditions: Stroke, Ischemic

Treatments: Drug: Tenecteplase

Study type: Interventional

Funder types: Other

Identifiers

NCT05657470

Y (2022) 187

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

TNK group

Experimental group

Treatment:

Drug: Tenecteplase

control group

No Intervention group