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

Beijing Tiantan Hospital2,004 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,004

Conditions

Intracranial Artery Occlusion With Infarction (Disorder)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria 1. Age ≥ 18 years old; 2. Diagnosis of acute ischemic stroke; 3. Imaging confirmed intracranial large artery occlusion (LVO): intracranial internal carotid artery (ICA T/L), 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); 4. Initiation of any type of endovascular treatment (EVT), including intra-arterial thrombolysis, mechanical thrombectomy, angioplasty, and stenting; 5. The patient or the patient's legal representative is able and willing to sign the informed consent. Exclusion criteria 1. Isolated cervical ICA or VA occlusion; 2. No evidence of LVO on DSA.

Outcomes

Primary Outcomes

Functional independence at 90 days (modified Rankin Scale of 0-2)

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.

Time frame: 90±7 days after enrollment

Symptomatic intracranial hemorrhage (sICH) within 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 frame: 12-36 hours after the procedure

Time from symptom onset to recanalization

Time frame: The end of the procedure

Secondary Outcomes

Recanalization rate at the end of the procedure

mTICI score 2b-3

Time frame: at the end of the procedure

Recanalization rate after the first attempt

mTICI score 2b-3

Time frame: At baseline, during the procedure, after the first attempt of endovascular treatment

Changes in NIHSS score immediately after the procedure

difference between NIHSS score immediately after the procedure and baseline

Time frame: within 2 hours after the procedure

Changes in NIHSS score 24 hours after the procedure

difference between NIHSS score 24 hours after the procedure and baseline

Time frame: 24 hours after the procedure

Changes in NIHSS score 7 days after the procedure or at discharge

difference between NIHSS score 7 days after the procedure or discharge and baseline

Time frame: 7 days after the procedure or discharge

EQ-5D 90 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.

Time frame: 90±7 days after the procedure

Barthel index (BI) 90 days after the procedure

The BI has a score of 0-100. A higher score indicates a better outcome.

Time frame: 90±7 days after the procedure

Parenchymal hematoma (PH2)

PH2 is defined as hematoma in \>30% of infarct area

Time frame: 12-36 hours after the procedure

Any intracranial hemorrhage on imaging

Time frame: 12-36 hours after the procedure

All-cause mortality within 90 days

Time frame: 90±7 days after the procedure

Time from onset to arrival

Time frame: At baseline, after arrival at the hospital

Time from arrival to imaging

Time frame: At baseline, after taking any brain imaging

Time from imaging to puncture

Time frame: At baseline, during the procedure, after successful groin puncture

Time from puncture to recanalization

Time frame: At baseline, during the procedure, after successful recanalization

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes