Endovascular Therapy, Stroke
Conditions
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREEndovascular Thrombectomy
Endovascular therapy includes direct mechanical thrombectomy or intravenous thrombolysis with mechanical thrombectomy. Endovascular Thrombectomy Device: Trepo trevor Retriever Device: SolitaireTM FR Revascularization Device
Sponsors
Fourth Affiliated Hospital, School of Medicine, Zhejiang University
Taizhou Hospital
Lishui Country People's Hospital
The Central Hospital of Lishui City
Shaoxing People's Hospital
Ganzhou People's Hospital
Luoyang Central Hospital
Huizhou Municipal Central Hospital
The Second Affiliated Hospital of Jiaxing University
Shanghai Zhongshan Hospital
The First People's Hospital of Huzhou
Taizhou First People's Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Good Functional Independence | 90 days | This outcome will look at the proportion of patients with mRS 0-2 at day 90. |
| Hemorrhage transformation | 24-hour | hemorrhage transformation at 24-hour after reperfusion therapy: * Hemorrhagic infarction 1 (HI1) was defined as small petechiae along the margins of the infarct; * Hemorrhagic infarction 2 (HI2) as confluent petechiae within the infarcted area but no space-occupying effect; * Parenchymal hemorrhage (PH1) as blood clots in 30% or less of the infarcted area with some slight space- occupying effect; and * Parenchymal hemorrhage (PH2) as blood clots in more than 30% of the infarcted area with substantial space- occupying effect. * Symptomatic intracranial hemorrhage was defined as blood at any site in the brain on the CT scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Poor outcome | 90 days | This outcome will look at the proportion of patients with mRS 3-6 at day 90. |
| The incidence of recurrent stroke or other vascular events | 90 days | The incidence of recurrent stroke and other vascular events at 90 days after endovascular therapy. |
Countries
China
Contacts
Primary ContactMin Lou, Ph.D
Outcome results
None listed