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Clinical Trials in China / NCT04201964
Recruiting Not applicable

Improving Neuroprotective Strategy for Ischemic Stroke With Poor Recanalization After Thrombectomy by Intra-arterial TNK (INSIST-TNK)

NCT04201964 · tracked via the Priya Life Science China tracker
Sponsor
Hui-Sheng Chen
Phase
Not applicable
Started
2019-12-15
Last updated
2026-09-11

Condition(s) studied

Ischemic Stroke

Investigational drug(s) / intervention(s)

Intra-arterial administration of tenecteplase

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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. 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 outcome measure(s)

  • Proportion of sufficient recanalization — immediately after local TNK treatment
    sufficient recanalization is defined as TICI 2b-3

Trial sites (1)

FacilityCityRegionStatus
General Hospital of Northern Theater Command Shenyang China Recruiting

More Hui-Sheng Chen trials in China

Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT) Recruiting
Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET) Recruiting

Other trials for the same condition

Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT) Recruiting
Efficacy and Safety Study of Ultra-early Mobile Stroke Unit Neuroprotection Combined With Revascularization for Acute Ischemic Stroke (EXCELLENT) Recruiting
A Phase 3 Trial of Lesion Network Mapping-Guided cTBS for Motor Recovery After Acute Ischemic Stroke Starting soon
Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA Recruiting
Prospective, Randomized, Parallel-Controlled Study of Brain Computer Interface Integrated Robotic Mirror Therapy for Post-Stroke Upper Limb Motor Function Disorder Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04201964 on ClinicalTrials.gov ↗ ← All trials in China