Ischemic Stroke
Conditions
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.
Interventions
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.
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years; 2. Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy; 3. The subtype of ischemic stroke is large-artery atherosclerosis according to TOAST classification; 4. The availability of informed consent.
Exclusion criteria
1. Other sub-types of ischemic stroke such as cardioembolism. 2. Hemorrhagic stroke such as cerebral hemorrhage, subarachnoid hemorrhage. 3. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (\<100000/mm3). 4. 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. 5. Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg). 6. Patients allergic to any ingredient of drugs in our study. 7. Unsuitable for this clinical studies assessed by researcher.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of sufficient recanalization | Immediately after TNK treatment | sufficient recanalization is defined as TICI 2b-3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| incidence of symptomatic intracranial haemorrhage | 48 hours | more than 4 increase in NIHSS caused by intracranial bleeding |
Countries
China
Outcome results
None listed