Boosting REcanalization of Thrombectomy for Ischemic Stroke by Intra-arterial TNK (BRETIS-TNK)

Ischemic Stroke Clinical Trial

Official title:

Boosting REcanalization of Thrombectomy for Ischemic Stroke by Intra-arterial TNK (BRETIS-TNK): a Prospective, Random, Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04202458
• Other study ID #: k(2019)29
• Status: Completed
• Phase: N/A
• Start date: December 15, 2019
• Est. completion date: November 22, 2021

Study information

• Verified date: November 2021
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Thrombolysis and endovascular thrombectomy are the most efficient treatments for acute ischemic stroke patients in time window. However, sufficient recanalization (mTICI2b-3) can 't be acquired in all patients under 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 whether a combination of thrombectomy and intra-arterial TNK administration can increase recanalization rate after the first attempt of thrombectomy device pass for ischemic Stroke.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 22, 2021
• Est. primary completion date: August 20, 2021
• 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. The subtype of ischemic stroke is large-artery atherosclerosis according to TOAST classification;

4. The availability of informed consent.

Exclusion Criteria:

1. Other sub-types of ischemic stroke such as cardioembolism.

2. Hemorrhagic stroke such as cerebral hemorrhage, subarachnoid hemorrhage.

3. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (<100000/mm3).

4. 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.

5. Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg).

6. Patients allergic to any ingredient of drugs in our study.

7. Unsuitable for this clinical studies assessed by researcher.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• intra-arterial tenecteplase administration
Intra-arterial administration of 4mg tenecteplase is given after microcatheter navigation through the clot. Intra-arterial administration of tenecteplase (0.4 mg/min) continuously is given after the first attempt of thrombectomy device pass for 30 minutes, and then followed by DSA.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	incidence of symptomatic intracranial haemorrhage	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 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