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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Endovascular Therapy
• Intervention / Treatment: Procedure: Endovascular Thrombectomy

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients will receive endovascular therapy, including direct endovascular therapy or intravenous thrombolysis with endovascular therapy.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Good Functional Independence	This outcome will look at the proportion of patients with mRS 0-2 at day 90.	90 days
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Poor outcome	This outcome will look at the proportion of patients with mRS 3-6 at day 90.	90 days
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: IS-EVT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No