Hongpai Medical Completes Pivotal Clinical Trial Enrollment for Sinuous® Heparin-Coated Peripheral Vascular Covered Stent

Recently, Shanghai Hongpai Medical Sinuous^®Heparin-Coated Peripheral Vascular Covered Stent Completes Clinical Enrollment of All Subjects.

This study is the first prospective, multicenter, single-arm, objective performance criteria (OPC) clinical trial in China to evaluate the safety and efficacy of heparin-coated peripheral vascular covered stents for stenotic or occlusive lesions associated with hemodialysis access. Led by Professor Zhao Yu, with The First Affiliated Hospital of Chongqing Medical University serving as the lead site, the trial involved 11 authoritative clinical centers across China and was completed over nine months. Currently, experts from all participating centers have highly recognized the product’s safety and operability. During the trial, the significant variability in patients’ lesions necessitated a wide range of product specifications, posing new challenges for clinical product preparation. The team at Hongpai Company maintained close communication with experts and promptly provided more suitable products for patients, ensuring the smooth progress of the project.

Postoperative Angiography

Currently, there are approximately 132 million patients with chronic kidney disease (CKD) in China, including about 670,000 patients undergoing dialysis. As the preferred vascular access for maintenance hemodialysis patients, the arteriovenous fistula (AVF) serves as the “lifeline” for hemodialysis in patients with end-stage renal disease (ESRD). Stenosis of the arteriovenous fistula is the most common complication and the primary cause of AVF failure. Covered stents are among the key medical devices used to treat such conditions. However, the domestic market is currently monopolized by imported products, with each stent priced as high as RMB 30,000–40,000, imposing a significant financial burden on patients. In recent years, under the leadership of Professor Zhao Yu, the Jinshan Hemodialysis Access Center at the First Affiliated Hospital of Chongqing Medical University has collaborated closely with domestic enterprises. Based on in-depth research into the characteristics of stenotic and occlusive lesions in hemodialysis access, they have made targeted improvements and enhancements to product design and manufacturing processes. This heparin-coated covered stent for dialysis access, featuring independent intellectual property rights in China, fills a long-standing gap in the domestic treatment landscape.