Stroke is the first cause of death in China. Intravenous thrombolysis and early endovascular treatment can significantly improve the outcome of patients with ischemic stroke. With the continuous deepening of research, the time window of endovascular interventional therapy has been extended from 6 h to 24 h. Tissue stratification plays a vital role in the expansion of time window. This article reviews the implications of tissue stratification, imaging assessment methods, and their significance in endovascular treatment.

Objective:To evaluate the characteristics of carotid plaque and the immediate outcomes after carotid artery stenting (CAS) in diabetic and non-diabetic patients by optical coherence tomography (OCT).Methods:Patients underwent CAS and OCT before and after operation in the Department of Neurology, Jinling Hospital from January 2014 to March 2019 were enrolled retrospectively. The clinical features, the characteristics of carotid plaque on OCT and the immediate outcomes after CAS were compared between diabetic group and non-diabetic group. The risk factors of stent malapposition were analyzed.Results:A total of 46 patients were enrolled. Their age was 64.02±8.32 years and 41 were males (89.1%). There were 20 patients (43.5%) in the diabetes group and 26 (56.5%) in the non-diabetes group. The proportions of atherosclerotic plaque with thin fibrous cap (40.0% vs. 7.7%; χ2=5.166, P=0.023), plaque rupture (55.0% vs. 23.1%; χ2=4.945, P=0.026) and macrophage infiltration (60.0% vs. 30.8%; χ2=3.930, P=0.047) in the diabetic group were significantly higher than those in the non-diabetic group. Multivariate logistic regression analysis showed that older age (odds ratio [ OR] 1.208, 95% confidence interval [ CI] 1.033-1.413; P=0.018), coronary heart disease ( OR 15.953, 95% CI 1.142-222.952; P=0.040), alcohol consumption ( OR 6.192, 95% CI 1.098-34.923; P=0.039) and lower systolic blood pressure ( OR 0.944, 95% CI 0.894-0.997; P=0.037) were independently associated with stent malaposition. Conclusion:Compared with the non-diabetic patients, carotid plaque in diabetic patients may be more unstable. Older age, coronary heart disease, alcohol consumption and lower systolic blood pressure were associated with stent malaposition after carotid stenting. OCT can reveal the characteristics of carotid plaque and the immediate outcomes after CAS, which can provide strong evidence for treatment decision.

Clinical trials are an important method for evaluating the safety and efficacy of in vitro diagnostic reagents, and are a key basis for product registration review and approval. In order to strengthen the management of clinical trials of in vitro diagnostic reagents, the National Medical Products Administration and relevant departments have formulated a series of regulations at the regulatory level, and require applicants and clinical trial institutions to establish a quality management system for clinical trials of in vitro diagnostic reagents. Medical laboratory is the main department and implementer of in vitro diagnostic reagent clinical trials in medical institutions. In recent years, with the rapid development of the in vitro diagnostic industry, the clinical trial projects of in vitro diagnostic reagents conducted by medical laboratory have been increasing day by day. However, there are currently few discussions on the clinical trial of in vitro diagnostic reagents from the perspective of researchers. Therefore, this article summarizes the characteristics of clinical trials of in vitro diagnostic reagents, analyzes the problems and difficulties in conducting clinical trials of in vitro diagnostic reagents in current medical laboratories, and introduces the laboratory′s experience in management; to provide reference for medical testing laboratories that have not yet conducted or have already conducted clinical trials of in vitro diagnostic reagents, in order to improve the quality and efficiency of clinical trials.

Clinical trials are an important method for evaluating the safety and efficacy of in vitro diagnostic reagents, and are a key basis for product registration review and approval. In order to strengthen the management of clinical trials of in vitro diagnostic reagents, the National Medical Products Administration and relevant departments have formulated a series of regulations at the regulatory level, and require applicants and clinical trial institutions to establish a quality management system for clinical trials of in vitro diagnostic reagents. Medical laboratory is the main department and implementer of in vitro diagnostic reagent clinical trials in medical institutions. In recent years, with the rapid development of the in vitro diagnostic industry, the clinical trial projects of in vitro diagnostic reagents conducted by medical laboratory have been increasing day by day. However, there are currently few discussions on the clinical trial of in vitro diagnostic reagents from the perspective of researchers. Therefore, this article summarizes the characteristics of clinical trials of in vitro diagnostic reagents, analyzes the problems and difficulties in conducting clinical trials of in vitro diagnostic reagents in current medical laboratories, and introduces the laboratory′s experience in management; to provide reference for medical testing laboratories that have not yet conducted or have already conducted clinical trials of in vitro diagnostic reagents, in order to improve the quality and efficiency of clinical trials.