Clinical trial NCT03909438: Investigation and Study on the Status of Endovascular Therapy in Acute Ischemic Stroke Ischemic Stroke
Official title: Investigation and Study on the Status of Endovascular Therapy in Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Endovascular Therapy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Fourth Affiliated Hospital, School of Medicine, Zhejiang University
name: Taizhou Hospital
name: Lishui Country People's Hospital
name: The Central Hospital of Lishui City
name: Shaoxing People's Hospital
name: Ganzhou People's Hospital
name: Luoyang Central Hospital
name: Huizhou Municipal Central Hospital
name: The Second Affiliated Hospital of Jiaxing University
name: Shanghai Zhongshan Hospital
name: The First People's Hospital of Huzhou
name: Taizhou First People's Hospital
First posted: 2019-04-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients will receive endovascular therapy, including direct endovascular therapy or intravenous thrombolysis with endovascular therapy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Good Functional Independence
timeFrame: 90 days
measure: Hemorrhage transformation
timeFrame: 24-hour
Secondary outcomes:
measure: Poor outcome
timeFrame: 90 days
measure: The incidence of recurrent stroke or other vascular events
timeFrame: 90 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Min Lou, Ph.D
role: STUDY_DIRECTOR
References: