Boosting REcanalization of Thrombectomy for Ischemic Stroke by Intra-arterial TNK (BRETIS-TNK): a Prospective, Random, Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- intra-arterial tenecteplase administration
- Conditions
- Ischemic Stroke
- Sponsor
- General Hospital of Shenyang Military Region
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Proportion of sufficient recanalization
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Hui-Sheng Chen
Professor
General Hospital of Shenyang Military Region
Eligibility Criteria
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.
Arms & Interventions
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
Intervention: intra-arterial tenecteplase administration
Outcomes
Primary Outcomes
Proportion of sufficient recanalization
Time Frame: Immediately after TNK treatment
sufficient recanalization is defined as TICI 2b-3
Secondary Outcomes
- Proportion of favorable outcome(90 days)
- proportion of early neurological improvement(48 hours)