Clinical trial NCT04201964: Improving Neuroprotective Strategy for Ischemic Stroke With Poor Recanalization After Thrombectomy by Intra-arterial TNK (INSIST-TNK)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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. insufficient perfusion (mTICI 1/2a) after endovascular treatment;
4. The availability of informed consent.

Exclusion Criteria:

1. Sufficient recanalization (TICI 2b-3);
2. More than 3 times of thrombectomy device passes
3. Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage
4. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia ( \<100000/mm3)
5. 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
6. Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg)
7. Patients allergic to any ingredient of drugs in our study
8. Unsuitable for this clinical studies assessed by researcher

Primary outcomes:
measure: Proportion of sufficient recanalization
timeFrame: immediately after local TNK treatment
Secondary outcomes:
measure: Proportion of favorable outcome
timeFrame: 90 days
measure: proportion of early neurological improvement
timeFrame: 48 hours
Other outcomes:
measure: incidence of symptomatic intracranial haemorrhage
timeFrame: 48 hours
Locations:
city: ShenYang
country: China
facility: General Hospital of Northern Theater Command
Study officials:
References: