Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients

Recruiting

• Conditions: Endovascular Treatment

• Registration Number: NCT05988125
• Lead Sponsor: Tingyu-Yi

Brief Summary

To investigate the real situation of assessment, diagnosis and treatment of acute ischemic stroke patients with endovascular therapy.

Detailed Description

Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients is an academic,independent, pragmatic , prospective, multicenter, observational registry study. The acute ischemic stroke patients undergone endovascular therapy will be enrolled in stroke centers. Baseline information and clinical follow-up information at 90 days of stroke onset are collected. Data collected include demographics, comorbidities, pathogenesis, blood pressures, stroke severity on admission, time intervals, reperfusion condition, and functional outcome, et al. The study aims to investigate the real situation of assessment, diagnosis and treatment of acute ischemic stroke patients with endovascular therapy.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2023-08-04
• Study First Submitted QC: 2023-08-10
• Study First Posted: 2023-08-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Acute ischemic stroke;
2. Brain imaging confirmed intracranial large vessel occlusion: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA V4), and posterior cerebral artery (PCA P1);
3. Initiation of any type of endovascular treatment, including mechanical thrombectomy, aspiration, angioplasty, and stenting;
4. Informed Consent as documented by signature or fulfilling the criteria for emergency consent/ deferral consent

Exclusion Criteria

1. Acute intracranial haemorrhage
2. No evidence of large vessel occlusion on digital subtraction angiography.
3. Patient bedridden or presenting from a nursing home
4. Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad) -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The modified Rankin Scale score at 90 days	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.

Secondary Outcome Measures

Name	Time	Method
Successful reperfusion rate	90 days
symptomatic intracranial hemorrhage or death within 90 days after stroke onset.	90 days

Trial Locations

Locations (6)

Department of Neurology, The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Gansu provincial hospital of TCM; 🇨🇳 Lanzhou, Gansu, China

Songyuan Jilin Oilfield Hospital; 🇨🇳 SongYuan, Jilin, China

Zhangzhou Municipal Hospital; 🇨🇳 Zhangzhou, Fujian, China

Jiamusi Central Hospital; 🇨🇳 Jiamusi, Heilongjiang, China

Shenyang First People's Hospital; 🇨🇳 Shenyang, Liaoning, China