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Not Yet Recruiting NCT05657470

Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)

Conditions: Stroke, Ischemic

Sex: All
Ages: 18 Years – N/A
Phase: PHASE2, PHASE3
Enrollment: 80
Sponsor: General Hospital of Shenyang Military Region

Location: China

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05657470). StuddyBuddy aggregates publicly available trial information.