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

Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04201964
• Other study ID #: k(2019)30
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: General Hospital of Shenyang Military Region
• Contact: Zi-Ai Zhao, Doctor
• Phone: +86 17790998175
• Email: zhaoziai[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
China	General Hospital of Northern Theater Command	ShenYang

Sponsors (1)

Lead Sponsor	Collaborator
Hui-Sheng Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	incidence of symptomatic intracranial haemorrhage	intracranial haemorrhage is defined as more than 4 increase in NIHSS caused by intracranial bleeding	48 hours
Primary	Proportion of sufficient recanalization	sufficient recanalization is defined as TICI 2b-3	immediately after local TNK treatment
Secondary	Proportion of favorable outcome	favorable outcome is defined as mRS 0-2	90 days
Secondary	proportion of early neurological improvement	early neurological improvement is defined as more than 4 decrease in NIHSS	48 hours