Acute Ischemic Stroke Registry for Endovascular Treatment

Acute Ischemic Stroke Clinical Trial

Official title:

Acute Ischemic Stroke Registry for Endovascular Treatment in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05213754
• Other study ID #: AIS-EVT
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: June 2023

Study information

• Verified date: January 2022
• Source: Capital Medical University
• Contact: Xunming Ji, MD
• Phone: 010-83198952
• Email: jixm[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The Acute Ischemic Stroke Registry for Endovascular Treatment (AIS-EVT) is an academic, prospective, multicenter, observational registry study. Consecutive stroke patients treated with endovascular treatment 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Diagnosis of acute ischemic stroke;

2. 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 intra-arterial thrombolysis, mechanical thrombectomy, aspiration, angioplasty, and stenting;

4. Verbal and written informed consent was provided at the time of admission by patients or their legal authorized representatives.

Exclusion Criteria:

No evidence of large vessel occlusion on digital subtraction angiography.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Procedure:
• Endovascular Treatment
Re-open the occluded cerebral artery using endovascular treatment

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

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