Investigation and Study on the Status of Endovascular Therapy in Acute Ischemic Stroke Ischemic Stroke (IS-EVT)

Zhejiang University

Status: Enrolling

Conditions: Stroke; Endovascular Therapy

Treatments: Procedure: Endovascular Thrombectomy

Study type: Observational

Funder types: Other

Identifiers

NCT03909438

IS-EVT

Details and patient eligibility

About

This study aims to build a database for patients with acute ischemic stroke who receive endovascular therapy and analyze the current situation, effectiveness, safety and cost-effectiveness of endovascular therapy for acute ischemic stroke in China.

Full description

Study design is a registry, prospective, multicenter study of acute ischemic stroke patients with endovascular treatment. A database will be established including age, gender, smoking history, blood pressure, blood glucose, previous history (such as coronary heart disease, atrial fibrillation, hypertension, diabetes, stroke history, etc.), history of antiplatelet drugs, onset to treatment time, National Institute of Health Stroke Scale (NIHSS) score before treatment.

Indications for endovascular therapy refer to the current guidelines. All patients will receive endovascular therapy, including direct endovascular therapy or intravenous thrombolysis with endovascular therapy. The effectiveness, safety and cost-effectiveness of endovascular therapy for acute ischemic stroke will be analyzed.

This study will enroll up at least 1,000 patients in 70 centers in China. The primary end point are proportion of patients with good prognosis after 90 days and intracranial hemorrhage transformation type after 24 hours.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke
2. Age ≥18 years
3. NIHSS ≥ 6
4. ICA or MCA-M1 or MCA-M2 occlusion as evidenced by MRA or 4D-CTA
5. Ethrombectomy can be initiated (femoral puncture) within 6 hours after onset or between 6 and 24 hours after time last know well if conform to the imaging inclusion criteria: Target Mismatch Profile on CT perfusion or MR perfusion: ischemic core volume is ≤ 70 ml, mismatch ratio is ≥ 1.8, penumbra volume is ≥ 15 ml.

Exclusion criteria

1. Large area cerebral infarction of anterior circulation on early CT image (more than 1/3 of cerebral hemisphere)
2. Blood glucose <2.7mmol/L or >22.2mmol/L
3. Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 90 days
4. Pregnant