Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window.

The modified Rankin Scale (mRS) is used to assess the status of neurological function recovery in patients after stroke. By evaluating the independence of patients in daily activities, it classifies functional levels into grades 0-6 (Grade 0 indicates no symptoms at all, Grades 1-5 correspond to functional impairments ranging from mild to severe, and Grade 6 indicates death).

Defined by ECASS III: any intraparenchymal or intracranial hemorrhage associated with clinical deterioration, where the latter is defined as an increase of ≥4 points in the National Institutes of Health Stroke Scale [NIHSS] score or death, with confirmation that the hemorrhage is the cause of neurological deterioration.

The proportion of randomized patients who died within 90 days

For the Global Use of Strategies to Open Occluded Arteries (GUSTO) Classification, its core lies in categorizing bleeding into three grades-mild, moderate, and severe-based on the impact of bleeding on the patient's clinical status, treatment needs, and prognosis.

Adverse Event (AE) refers to any adverse medical event that occurs in a participant after administration of an investigational medicinal product. It may present as signs, symptoms, diseases, or abnormal laboratory findings, but it is not necessarily causally related to the investigational medicinal product. A Serious Adverse Event (SAE) refers to a special safety event among AEs that meets any of the following criteria: "resulting in death, life-threatening, requiring hospitalization/prolongation of existing hospitalization, causing permanent or severe disability/incapacity, leading to congenital anomalies/birth defects, or being another important medical event".

The modified Rankin Scale (mRS) is used to assess the status of neurological function recovery in patients after stroke. By evaluating the independence of patients in daily activities, it classifies functional levels into grades 0-6 (Grade 0 indicates no symptoms at all, Grades 1-5 correspond to functional impairments ranging from mild to severe, and Grade 6 indicates death).

The modified Rankin Scale (mRS) is used to assess the status of neurological function recovery in patients after stroke. By evaluating the independence of patients in daily activities, it classifies functional levels into grades 0-6 (Grade 0 indicates no symptoms at all, Grades 1-5 correspond to functional impairments ranging from mild to severe, and Grade 6 indicates death).

The National Institutes of Health Stroke Scale (NIHSS) is a globally accepted tool for assessing the severity of stroke. Primarily used in patients with acute stroke, it evaluates 11 neurological domains including consciousness, gaze, visual fields, facial palsy, limb motor function, sensation, and language. Scores ranging from 0 to 42 are assigned based on the degree of impairment, where a score of 0 indicates normal neurological function and a score of 42 indicates extremely severe impairment.

The National Institutes of Health Stroke Scale (NIHSS) is a globally accepted tool for assessing the severity of stroke. Primarily used in patients with acute stroke, it evaluates 11 neurological domains including consciousness, gaze, visual fields, facial palsy, limb motor function, sensation, and language. Scores ranging from 0 to 42 are assigned based on the degree of impairment, where a score of 0 indicates normal neurological function and a score of 42 indicates extremely severe impairment.

The Barthel Index (BI) is a commonly used tool to assess the ability of self-care in daily life for patients with functional impairments (such as those with stroke or spinal cord injury). It mainly evaluates whether patients can independently perform 10 daily activities including eating, dressing, walking, and using the toilet, and assigns a score ranging from 0 to 100 based on their ability level: a score of 100 indicates complete self-care, and the lower the score, the higher the degree of dependence on others.

The rate of favorable reperfusion is defined as an improvement of 90% or more in the area with Tmax > 6s (compared with the previous status) on imaging examinations.

The volume of irreversible cerebral infarction refers to the brain tissue that has suffered irreversible damage after ischemia, and is also called the volume of core infarction.

The Thrombolysis in Cerebral Infarction (TICI) Scale is a standard for assessing the degree of cerebral vascular recanalization in patients with acute ischemic stroke after endovascular treatment. It evaluates the blood flow recovery of the infarct-related artery via imaging examinations and is mainly categorized into Grades 0 to 3: Grade 0 represents no perfusion, Grade 1 mild perfusion, Grade 2 partial perfusion, and Grade 3 complete perfusion.