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Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV Fistula

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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.

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