Boosting REcanalization of Thrombectomy for Ischemic Stroke by Intra-arterial TNK (BRETIS-TNK)

Study Overview
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Brief Summary
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Thrombolysis and endovascular thrombectomy are the most efficient treatments for acute ischemic stroke patients in time window. However, sufficient recanalization (mTICI2b-3) can 't be acquired in all patients under thrombectomy. The EXTEND-IA TNK study indicated that tenecteplase before thrombectomy was associated with a higher incidence of reperfusion and better functional outcome than alteplase among patients with ischemic stroke treated within 4.5 hours after symptom onset. This study intends to explore whether a combination of thrombectomy and intra-arterial TNK administration can increase recanalization rate after the first attempt of thrombectomy device pass for ischemic Stroke.

Official Title
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Boosting REcanalization of Thrombectomy for Ischemic Stroke by Intra-arterial TNK (BRETIS-TNK): a Prospective, Random, Pilot Study

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: intra-arterial tenecteplase administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years; Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy; The subtype of ischemic stroke is large-artery atherosclerosis according to TOAST classification; The availability of informed consent. Exclusion Criteria: Other sub-types of ischemic stroke such as cardioembolism. Hemorrhagic stroke such as cerebral hemorrhage, subarachnoid hemorrhage. 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), increase in 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 allergic to any ingredient of drugs in our study. Unsuitable for this clinical studies assessed by researcher.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intra-arterial tenecteplase administration<br>Intra-arterial administration of 4mg tenecteplase is given after microcatheter navigation through the clot. Intra-arterial administration of tenecteplase (0.4 mg/min) continuously is given after the first attempt of thrombectomy device pass for 30 minutes, and then followed by DSA | Drug: intra-arterial tenecteplase administration<br>* Intra-arterial administration of 4mg tenecteplase is given after microcatheter navigation through the clot. Intra-arterial administration of tenecteplase (0.4 mg/min) continuously is given after the first attempt of thrombectomy device pass for 30 minutes, and then followed by DSA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of sufficient recanalization | sufficient recanalization is defined as TICI 2b-3 | Immediately after TNK treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of favorable outcome | favorable outcome is defined as mRS 0-2 | 90 days | 
| proportion of early neurological improvement | early neurological improvement is defined as more than 4 decrease in NIHSS | 48 hours |