Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients

Endovascular Treatment Clinical Trial

Official title:

Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05988125
• Other study ID #: ETERNITY
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: March 31, 2025

Study information

• Verified date: January 2024
• Source: Zhangzhou Municipal Hospital
• Contact: Wen-huo Chen, bachelor
• Phone: +86-05962082582
• Email: doctorwwenhuo[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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) -

Related Conditions & MeSH terms

• Endovascular Treatment
• Ischemic Stroke

Locations

Country	Name	City	State
China	Jiamusi Central Hospital	Jiamusi	Heilongjiang
China	Gansu provincial hospital of TCM	Lanzhou	Gansu
China	Department of Neurology, The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Shenyang First People's Hospital	Shenyang	Liaoning
China	Songyuan Jilin Oilfield Hospital	SongYuan	Jilin
China	Zhangzhou Municipal Hospital	Zhangzhou	Fujian

Sponsors (2)

Lead Sponsor	Collaborator
Wen-huo Chen	First People's Hospital of Shenyang

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
Secondary	Successful reperfusion rate		90 days
Secondary	symptomatic intracranial hemorrhage or death within 90 days after stroke onset.		90 days