Abstract: To explore the systematic design of clinical trials for iliac vein stents. By reviewing registered clinical studies on iliac vein stents that have been marketed in China and the United States in recent years, a comprehensive analysis has been conducted on key elements, including subjects' inclusion and exclusion criteria, imaging examination methods, primary endpoints, single-arm target value setting, secondary endpoints, and subgroup analysis The design of clinical trials for iliac vein stents should be based on the characteristics of the disease, device properties, and the purpose of the study. Clinical trial design encompasses critical elements such as selecting appropriate study populations, establishing rational evaluation endpoints, etc. Additionally, a thorough assessment of the risk-benefit profile during clinical use is essential to facilitate the scientific development of such medical devices.