Clinical Research Directory

Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).

The primary objective of this study is to collect real-world performance and safety data on the Penumbra System in a patient population with acute ischemic stroke (AIS)

Acute Ischemic Stroke Involves Significant Inflammatory Response. This Prospective Cohort Study Evaluates the Predictive Value of Monocyte-, Neutrophil-, and Leukocyte-to-albumin Ratios for Stroke Severity and Functional Outcome Using NIHSS at Admission and Modified Rankin Scale During Follow-up.

Acute Ischemic Stroke is a leading cause of mortality and long-term disability worldwide. Increasing evidence suggests that systemic inflammation plays a significant role in the pathophysiology and progression of ischemic brain injury. Recently, several inflammatory biomarkers derived from routine laboratory tests have been investigated as potential predictors of stroke severity and clinical outcome. This prospective cohort study aims to evaluate the predictive utility of the monocyte-to-albumin ratio, neutrophil-to-albumin ratio, and total leukocytic count-to-albumin ratio in patients with acute ischemic stroke. These indices combine inflammatory cell counts with serum albumin levels and may reflect both systemic inflammatory status and nutritional condition. Stroke severity will be assessed at admission using the NIH Stroke Scale, while functional outcome will be evaluated during follow-up using the Modified Rankin Scale. The study aims to determine whether these simple and readily available biomarkers can serve as reliable predictors of stroke severity and prognosis in patients with acute ischemic stroke.

Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

Since 2015, many randomized trials have shown that endovascular thrombectomy improve functional outcomes in acute ischemic stroke patients with large vessel occlusion. Recently, five randomized controlled trials (ANGEL-ASPECT \[Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core\], LASTE \[LArge Stroke Therapy Evaluation\], RESCUE-Japan LIMIT \[The Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism-Japan Large Ischemic Core Trial\], SELECT 2 \[Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke\], and TENSION \[The Efficacy and Safety of Thrombectomy in Stroke with extended lesion and extended time window\]) demonstrated the efficacy and safety of thrombectomy for large infarct patients (defined as Alberta Stroke Program Early Computed Tomography Score \[ASPECTS\] ≥3 or infarct core \<100ml). Patients with extra-large infarct core (ASPECTS score of 2 or less) were excluded from these trials. Therefore, the efficacy of endovascular thrombectomy in patients with extra-large ischemic burden has not been well studied. The XL STROKE registry is aiming to investigate the clinical outcomes and safety of mechanical thrombectomy in acute extra-large ischemic stroke.

Exploration and Establishment of an Early Warning System for Futile Reperfusion - A I S

The goal of this prospective cohort registration study is to establish an early warning system for futile recanalization in acute ischemic stroke by analyzing multi-omics information to identify key regulatory nodes and target molecules in ineffective recanalization. The core issue addressed by this research is: Identifying key regulatory nodes and target molecules closely associated with futile recanalization, revealing the interactions among the neurovascular unit, peripheral immune cells, and the brain lymphatic system, as well as developing early diagnostic biomarkers and novel diagnostic technologies for futile recanalization.

Intravenous Thrombolytic Therapy for Acute Ischemic Stroke Patients with Low NIHSS and Non-disabling Deficits

Minor stroke is considered an acute ischemic stroke (AIS) that has a National Institute of Health Stroke Scale (NIHSS) score ≤ 5 points. About 1/3 patients with mild stroke have poor prognosis, whether patients with this type undergo thrombolysis has been a controversial issue. A pooled analysis published in the Lancet in 2014 included 9 high-quality RCT studies of intravenous thrombolysis such as NINDS and IST3, and a total of 666 (10%) patients with mild stroke were included in the analysis. For mild stroke, the proportion of good prognosis in the control group and the alteplase group was 58.9% and 68.7% (OR 1.48, 95%Cl 1.07-2.06), respectively. Therefore, guidelines recommended alteplase thrombolytic therapy for patients with mild stroke. However, PRISMS, a randomized controlled trial of intravenous thrombolytic therapy for mild stroke published in 2018, found that alteplase intravenous thrombolytic therapy did not improve clinical outcomes compared with aspirin in patients with mild non-disabled stroke (90-day mRS 0-1 ratio 78.2% vs 81.5%), and the incidence of symptomatic intracranial hemorrhage was higher. However, a major limitation of the PRISMS study was that more than 85% of patients had numbness and dysarticulation, so this conclusion cannot be extrapolated to patients with other mild stroke symptoms. Moreover, due to the early termination of the sponsorship of this trial, the number of enrolled cases did not reach the pre-designed number, resulting in a serious decline in the authenticity of the study results. Symptoms and outcomes of minor stroke are important criteria for assessment. However, there is currently no uniform standard for the assessment of disability. Both international and domestic guidelines recommend IVT with alteplase for minor disabling stroke within 4.5h, but not routinely recommend intravenous thrombolysis for minor nondisabling stroke within 4.5h. It is important to underline that strokes with low NIHSS scores are not necessarily nondisabling. Despite, patients with mild stroke symptoms are often excluded from IVT due to safety concerns potentially outweighing the putative benefits of recanalization therapy. Therefore, the investigators developed a new definition to refine the disability assessment of stroke symptoms. The purpose of this study was to investigate whether AIS patients with NIHSS ≤ 5, a limb-related NIHSS item score of 0, and with any of the following NIHSS item ≥2: Best Gaze, Visual, Facial palsy, Limb ataxia, Sensory, Best language, Dysarthria, Extinction and Inattention, could benefit from intravenous thrombolysis.

A Phase I Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of AAPB for Injection

This is a Phase I clinical to evaluate the safety and tolerability of single and multiple intravenous infusions of AAPB at different doses over 7 consecutive days.