Investigation and Study on the Status of Endovascular Therapy in Acute Ischemic Stroke Ischemic Stroke

Stroke Clinical Trial

— IS-EVT  

Official title:

Investigation and Study on the Status of Endovascular Therapy in Acute Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03909438
• Other study ID #: IS-EVT
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Lou, Ph.D
• Phone: 13958007213
• Email: loumingxc[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endovascular Therapy
• Ischemic Stroke
• Stroke

Intervention

Procedure:
• Endovascular Thrombectomy
Endovascular therapy includes direct mechanical thrombectomy or intravenous thrombolysis with mechanical thrombectomy. Endovascular Thrombectomy Device: Trepo trevor Retriever Device: SolitaireTM FR Revascularization Device

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (13)

Lead Sponsor

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

Fourth Affiliated Hospital, School of Medicine, Zhejiang University, Ganzhou People's Hospital, Huizhou Municipal Central Hospital, Lishui Country People's Hospital, Luoyang Central Hospital, Shanghai Zhongshan Hospital, Shaoxing People's Hospital, Taizhou First People's Hospital, Taizhou Hospital, The Central Hospital of Lishui City, The First People's Hospital of Huzhou, The Second Affiliated Hospital of Jiaxing University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Good Functional Independence	This outcome will look at the proportion of patients with mRS 0-2 at day 90.	90 days
Primary	Hemorrhage transformation	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.	24-hour
Secondary	Poor outcome	This outcome will look at the proportion of patients with mRS 3-6 at day 90.	90 days
Secondary	The incidence of recurrent stroke or other vascular events	The incidence of recurrent stroke and other vascular events at 90 days after endovascular therapy.	90 days