Improving Neuroprotective Strategy for Ischemic Stroke With Poor Recanalization After Thrombectomy by Intra-arterial TNK (INSIST-TNK)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intra-arterial administration of tenecteplase.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improving Neuroprotective Strategy for Ischemic Stroke With Poor Recanalization After Thrombectomy by Intra-arterial TNK (INSIST-TNK): a Prospective, Single Arm, Pilot Study
Overview
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).
Interventions
- Drug Intra-arterial administration of tenecteplase
Intra-arterial administration of tenecteplase (0.2-0.4 mg/min) immediately after thrombectomy device pass for 30-40 minutes.
Primary outcome measures
- Proportion of sufficient recanalization [Time frame: immediately after local TNK treatment]
Secondary outcome measures (2)
- Proportion of favorable outcome [Time frame: 90 days]
- proportion of early neurological improvement [Time frame: 48 hours]
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;
- insufficient perfusion (mTICI 1/2a) after endovascular treatment;
- The availability of informed consent.
Exclusion criteria
- 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)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- General Hospital of Northern Theater Command — Shenyang
Identifiers
NCT: NCT04201964 · k(2019)30