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

Not Applicable

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: intra-arterial tenecteplase administration

• Registration Number: NCT04202458
• Lead Sponsor: General Hospital of Shenyang Military Region

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-15
• Study First Submitted: 2019-12-15
• Study First Submitted QC: 2019-12-15
• Study First Posted: 2019-12-17
• Primary Completion: 2021-08-20
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-21
• Study Completion: 2021-11-22
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intra-arterial tenecteplase administration	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

Primary Outcome Measures

Name	Time	Method
Proportion of sufficient recanalization	Immediately after TNK treatment	sufficient recanalization is defined as TICI 2b-3

Secondary Outcome Measures

Name	Time	Method
Proportion of favorable outcome	90 days	favorable outcome is defined as mRS 0-2
proportion of early neurological improvement	48 hours	early neurological improvement is defined as more than 4 decrease in NIHSS

Trial Locations

Locations (1)

General Hospital of Northern Theater Command; 🇨🇳 ShenYang, China