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

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status: Completed

Conditions: Ischemic Stroke

Treatments: Drug: intra-arterial tenecteplase administration

Study type: Interventional

Funder types: Other

Identifiers

NCT04202458

k(2019)29

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

intra-arterial tenecteplase administration

Experimental group

Description:

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

Treatment:

Drug: intra-arterial tenecteplase administration