NCT04201964 Improving Neuroprotective Strategy for Ischemic Stroke With Poor Recanalization After Thrombectomy by Intra-arterial TNK (INSIST-TNK)
| NCT ID | NCT04201964 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hui-Sheng Chen |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2019-12-15 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2019-12-15 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04201964 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04201964 currently recruiting?
Yes, NCT04201964 is actively recruiting participants. Contact the research team at zhaoziai@hotmail.com for enrollment information.
Where is the NCT04201964 trial being conducted?
This trial is being conducted at Shenyang, China.
Who is sponsoring the NCT04201964 clinical trial?
NCT04201964 is sponsored by Hui-Sheng Chen. The trial plans to enroll 30 participants.
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