About this trial
In 2015, five randomized trials showed efficacy of endovascular thrombectomy over standard medical care in patients with acute ischemic stroke caused by occlusion of arteries of the proximal anterior circulation. However, sufficient recanalization (mTICI2b-3) can 't be acquired in all patients under thrombectomy. There is a lack of evidence that whether salvage intra-arterial thrombolysis is beneficial for patients with insufficient recanalization after endovascular 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 the proportion of sufficient recanalization (2b/3) after intra-arterial tenecteplase administration in patients undergoing thrombectomy with insufficient recanalization (1/2a).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
insufficient perfusion (mTICI 1/2a) after endovascular treatment;
The availability of informed consent.
Disqualifiers
Sufficient recanalization (TICI 2b-3);
More than 3 times of thrombectomy device passes
Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage
Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia ( <100000/mm3)
Trial design
Single group
Treatments tested in this trial
Intra-arterial administration of tenecteplase
DrugIntra-arterial administration of tenecteplase (0.2-0.4 mg/min) immediately after thrombectomy device pass for 30-40 minutes.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of sufficient recanalization
sufficient recanalization is defined as TICI 2b-3
Secondary outcomes
Proportion of favorable outcome
favorable outcome is defined as mRS 0-2
proportion of early neurological improvement
early neurological improvement is defined as more than 4 decrease in NIHSS
Other outcomes
incidence of symptomatic intracranial haemorrhage
intracranial haemorrhage is defined as more than 4 increase in NIHSS caused by intracranial bleeding
Sponsors and contacts
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Hui-Sheng Chen
Lead sponsor
General Hospital of Shenyang Military Region
Sponsor institution