研究单位:[1]Peking University First Hospital[2]BrosMed Medical Co., Ltd[3]CCRF Inc., Beijing, China[4]Peking University First Hospital,Beijing,China,100034[5]Beijing Tongren Hospital,Beijing,China,100730[6]The First Affiliated Hospital of Jinan University,Guangzhou,Guangdong,China,510630[7]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China,450052[8]The Second Affiliated Hospital of Nanjing Medical University,Nanjing,Jiangsu,China,210011[9]Longhua Hospital Shanghai University of Traditional Chinese Medicine,Shanghai,Shanghai,China,200032[10]Sir Run Run Shaw Hospital, Zhejiang University School of Medicine,Hangzhou,Zhengjiang,China,310016
研究目的:
This prospective, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Tri-wire Peripheral Balloon Dilatation Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.