Endovascular Treatment for AIS in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry

Endovascular Treatment Clinical Trial

Official title:

Endovascular Treatment for Acute Ischemic Stroke in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06078917
• Other study ID #: A "Real world" study-ETERNITY
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: October 2023
• Source: Zhangzhou Municipal Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To investigate the Endovascular Treatment difference between Chinese city and country hospital.

Description:

Endovascular Treatment for AIS in Chinese Municipal and County Hospitals： A "Real World" Study-ETERNITY Registry is an academic , independent, pragmatic , prospective , multicenter , observational registry study . Patients with acute ischemic stroke caused by anterior circulation intracranial large vessel occlusion and receiving EVT were included. Patients were divided into primary stroke center (county hospital) and senior stroke center (city hospital) groups. Acute ischemic stroke (AIS) workflow, EVT procedural details and clinical outcome were compared in two groups. The aim of the study was to explore the EVT difference in Chinese city and county hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1196
• Est. completion date: July 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

(1) age =18 years; (2) diagnosis of AIS caused by imaging-confirmed intracranial LVO, including isolated cervical internal carotid artery or tandem occlusion, intracranial internal carotid artery, middle cerebral artery (M1/M2), anterior cerebral artery (A1/A2); (3) initiation of any type of EVT, including mechanical thrombectomy, emergent angioplasty via balloon or/and stent; (4).Onset-to-presentation time with 24 hours; (5).Patients whose onset-to-presentation time surpass 6 hours should had CTP and fulfill with DAWN[6] or DEFUSE's[7] criteria. Exclusion Criteria: (1) Without follow up outcome; (2) posterior circulation stroke;(3)no evidence of LVO on angiogram.

Related Conditions & MeSH terms

• Endovascular Treatment
• Ischemic Stroke

Locations

Country	Name	City	State
China	Zhangzhou Municipal Hospital	Zhangzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Wen-huo Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The modified Rankin Scale score at 90 days	The range of the modified Rankin Scale is from 0 to 6. A higher score indicates a worse outcome.; 0-No symptoms; 1-No significant disability; 2-Slight disability; 3-Moderate disability; 4-Moderately severe disability; 5-Severe disability; 6-Dead.	90 days
Primary	Baseline CT/magnetic resonance and CT angiography/magnetic resonance angiography imaging, digital subtraction angiography	Radiological assessment included ASPECTS ,location of occlusion site, presence of underlying ICAS ,or exist microcatheter "First-Pass Effect".	90 days
Primary	Successful reperfusion	Successful reperfusion was defined as eTICI =2b	90 days