Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II)

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

Summary

A recent pilot study suggests intra-arterial tenecteplase (TNK) during the first pass of endovascular treatment (EVT) seems safe, may increase first-pass reperfusion and good outcome in acute ischemic stroke (AIS) patients with large vessel occlusion (LVO).

The study aimed to determine the efficacy and safety of intra-arterial TNK administration during EVT in AIS-LVO patients.

• Phase: 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:

• Age ≥18 years;

• Stroke patient with large vessel occlusion (ICA cervical or terminus, M1, M2, basilar) who meets criteria for endovascular treatment within 24 hours of stroke onset;

• The modified Rankin Scale (mRS) score before onset ≤ 2;

• ASPECTS 6 or greater on CT

• Signed informed consent.

Exclusion Criteria:

• hemorrhagic stroke;

• Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (<100000/mm3);

• Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), elevated serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;

• Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);

• Patients with contraindication or allergic to any ingredient of drugs in our study;

• Pregnancy, or plan to get pregnant or during active lactation;

• Suspected septic embolus or infective endocarditis

• 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.