Endovascular Treatment for AIS in Chine… | Clinical Trial

Key information

Conditions

Endovascular Treatment Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhangzhou Municipal Hospital

Zhangzhou, Fujian, 363000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

The modified Rankin Scale score at 90 days

Time frame: 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.
Baseline CT/magnetic resonance and CT angiography/magnetic resonance angiography imaging, digital subtraction angiography

Time frame: 90 days

Radiological assessment included ASPECTS ，location of occlusion site, presence of underlying ICAS ，or exist microcatheter "First-Pass Effect".
Successful reperfusion

Time frame: 90 days

Successful reperfusion was defined as eTICI ≥2b

Sponsors and collaborators

Lead sponsor

Wen-huo Chen

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2023
First posted: Oct 12, 2023
Registry last updated: Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed