Stent Implantation Versus Balloon Dilation for Acute Anterior Circulation Tandem Occlusion

The expanded treatment in cerebral infarction (eTICI) score

eTICI score (0,1,2a,2a\_50,2a\_67,2c,3) : Grade 0 : no perfusion Grade 1: penetration with minimal perfusion Grade 2a: partial filling of 1-49% of the vascular territory Grade 2b\_50 : partial filling of 50-66% of the vascular territory Grade 2b\_67: partial filling of 67-89% of the vascular territory Grade 2c: partial filling of 90-99% of the vascular territory Grade 3 : complete perfusion

Time frame: at the end of the endovascular procedure

Ipsilateral carotid residual stenosis rate

The extracranial stenosis was assessed by using criteria from the North American Symptomatic Carotid Endarterectomy Trial (NASCET). The residual stenosis rate of the ipsilateral internal carotid artery was assessed according to the last DSA angiography of the procedure.

Time frame: at the end of the endovascular procedure

The National Institutes of Health Stroke Scale (NIHSS) score

National Institutes of Health Stroke Scale (NIHSS) score. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The single patient assessment requires less than 10 minutes to complete. The evaluation of stroke severity depends upon the ability of the observer to accurately and consistently assess the patient. Higher scores mean a worse outcome.

Time frame: at 36 hours (±12 hours)

Proportion of NIHSS scores 0-1

The proportion of patients with an NIHSS score of 0-1 National Institutes of Health Stroke Scale (NIHSS) score. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The single patient assessment requires less than 10 minutes to complete. The evaluation of stroke severity depends upon the ability of the observer to accurately and consistently assess the patient. Higher scores mean a worse outcome.

Time frame: at 36 hours (±12 hours)

Change in National Institutes of Health Stroke Scale (NIHSS) score

The proportion of patients with an NIHSS score reduction of ≥4 points after randomization compared to baseline. NIHSS is 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. Higher scores mean a worse outcome.

Time frame: at 36 hours (±12 hours)

Rate of carotid stenosis

The extracranial stenosis was assessed by using criteria from the North American Symptomatic Carotid Endarterectomy Trial (NASCET) confirmed by cervical vascular ultrasound.

Time frame: at 5-7days or discharge

The NIHSS score

The NIHSS score NIHSS is 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. Higher scores mean a worse outcome.

Time frame: at 5-7days or discharge

The mRS scores

The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. The Modified Rankin Score (mRS) is the most widely used outcome measure in stroke clinical trials. Standardized interviews to obtain a mRS score are recommended at 3 months (90 days) following hospital discharge.

Time frame: at 90±7days and 180±14 days

Proportion of mRS score 0-3

The Modified Rankin Score (mRS) is a 6-point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. The Modified Rankin Score (mRS) is the most widely used outcome measure in stroke clinical trials. Standardized interviews to obtain an mRS score are recommended at 3 months (90 days) following hospital discharge. Higher scores mean a worse outcome.

Time frame: at 90±7days and 180±14 days

All-cause mortality

Rate of mortality at 90±14 days.

Time frame: at 90±7days

Rate of asymptomatic intracranial hemorrhage

Rate of symptomatic intracerebral hemorrhage at CT (Computerized Tomography) or MRI (Magnetic Resonance Imaging) at 36 hours (±12 hours) according to the Heidelberg classification (independent imaging core laboratory).

Time frame: at 36 hours (±12 hours)

The incidence of adverse events.

Any adverse medical event, whether causally related to the trial or not, that occurred between the start of patient randomization and the last follow-up visit was judged as an adverse event. The incidence of non-hemorrhagic adverse events.

Time frame: at 90±7days and 180±14 days

The incidence of serious adverse events.

A serious adverse event is defined as an adverse event that results in 1. Resulting in death; 2. Life-threatening (means that the subject is at risk of death at the time of an adverse event. It does not refer to those adverse events that could lead to death if the condition were assumed to be worse); 3. Requires hospitalization or prolonged hospitalization; 4. Resulting in persistent or severe disability or dysfunction 5. Resulting in a congenital anomaly or birth defect; 6. Medical events that, in the opinion of the investigator, can be judged as serious adverse events. The incidence of non-hemorrhagic serious adverse events.

Time frame: at 90±7days and 180±14 days