Boosting REcanalization of Thrombectomy for Ischemic Stroke by Intra-arterial TNK (BRETIS-TNK)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: intra-arterial tenecteplase administration 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
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.
|
Outcome Measures
Primary Outcome Measures
- Proportion of sufficient recanalization [Immediately after TNK treatment]
sufficient recanalization is defined as TICI 2b-3
Secondary Outcome Measures
- Proportion of favorable outcome [90 days]
favorable outcome is defined as mRS 0-2
- proportion of early neurological improvement [48 hours]
early neurological improvement is defined as more than 4 decrease in NIHSS
Other Outcome Measures
- incidence of symptomatic intracranial haemorrhage [48 hours]
more than 4 increase in NIHSS caused by intracranial bleeding
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years;
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Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy;
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The subtype of ischemic stroke is large-artery atherosclerosis according to TOAST classification;
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The availability of informed consent.
Exclusion Criteria:
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Other sub-types of ischemic stroke such as cardioembolism.
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Hemorrhagic stroke such as cerebral hemorrhage, subarachnoid hemorrhage.
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Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (<100000/mm3).
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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.
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Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg).
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Patients allergic to any ingredient of drugs in our study.
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Unsuitable for this clinical studies assessed by researcher.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | General Hospital of Northern Theater Command | ShenYang | China | 110840 |
Sponsors and Collaborators
- General Hospital of Shenyang Military Region
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- k(2019)29