Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke

Completed

• Conditions: Intracranial Artery Occlusion With Infarction (Disorder)

• Registration Number: NCT03370939
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

Endovascular thrombectomy (EVT) is effective and safe for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) in major clinical trials. Whether the benefit of EVT in randomized trials could be generalized to clinical practice, especially in developing countries, remains unknown. The prospective Chinese ANGEL-ACT Registry (Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke) was established to evaluate the utilization, and subsequent outcomes of EVT treated AIS patients. This study is a multi-center, prospective registry study initiated by researchers, funded by National Key R\&D Program of China. A total of 2,000 patients with acute ischemic stroke will undergo endovascular treatment. The hypothesis was that favorable outcomes from clinical trials could be achieved in clinical practice in China.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-18
• Study Start: 2017-11-11
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-13
• Primary Completion: 2019-07-07
• Study Completion: 2019-07-07
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2004

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional independence at 90 days (modified Rankin Scale of 0-2)	90±7 days after enrollment	The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;1-No significant disability;2-Slight disability;3-Moderate disability;4-Moderately severe disability;5-Severe disability;6 -Dead.A higher score indicates worse a outcome.
Symptomatic intracranial hemorrhage (sICH) within 12-36 hours after the procedure	12-36 hours after the procedure	Heidelberg Bleeding Classification): new intracranial hemorrhage detected by brain imaging associated with ≥4 points total National Institutes of Health Stroke Scale (NIHSS), ≥2 points in one NIHSS category, leading to intubation/ hemicraniectomy/ EVD placement or other major medical/surgical intervention, or absence of alternative explanation for deterioration
Time from symptom onset to recanalization	The end of the procedure

Secondary Outcome Measures

Name	Time	Method
Recanalization rate after the first attempt	At baseline, during the procedure, after the first attempt of endovascular treatment	mTICI score 2b-3
Changes in NIHSS score 24 hours after the procedure	24 hours after the procedure	difference between NIHSS score 24 hours after the procedure and baseline
Changes in NIHSS score 7 days after the procedure or at discharge	7 days after the procedure or discharge	difference between NIHSS score 7 days after the procedure or discharge and baseline
Barthel index (BI) 90 days after the procedure	90±7 days after the procedure	The BI has a score of 0-100. A higher score indicates a better outcome.
Recanalization rate at the end of the procedure	at the end of the procedure	mTICI score 2b-3
Changes in NIHSS score immediately after the procedure	within 2 hours after the procedure	difference between NIHSS score immediately after the procedure and baseline
EQ-5D 90 days after the procedure	90±7 days after the procedure	EQ-5D is a standardized instrument for measuring generic health status. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).A higher score indicates a better outcome.
Parenchymal hematoma (PH2)	12-36 hours after the procedure	PH2 is defined as hematoma in \>30% of infarct area
Any intracranial hemorrhage on imaging	12-36 hours after the procedure
All-cause mortality within 90 days	90±7 days after the procedure
Time from onset to arrival	At baseline, after arrival at the hospital
Time from arrival to imaging	At baseline, after taking any brain imaging
Time from imaging to puncture	At baseline, during the procedure, after successful groin puncture
Time from puncture to recanalization	At baseline, during the procedure, after successful recanalization

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China