研究单位：[1]The First Affiliated Hospital of Zhengzhou University[2]DK Medical Technology (Suzhou) Co., Ltd.[3]Beijing Tongren Hospital Affiliated to Capital Medical University,Beijing,China[4]Guangdong Provincial People''s Hospital,Guangzhou,Guangdong,China[5]South China Hospital of Shenzhen University,Shenzhen,Guangdong,China[6]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China[7]The Second Affiliated Hospital of Nanjing Medical University,Nanjing,Jiangsu,China[8]Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai,Shanghai,China[9]National University Hospital of Singapore,Singapore,Singapore
This is a multicenter, prospective, randomized controlled clinical study. Patients with hemodialysis arteriovenous graft fistula stenosis will be recruited to explore whether the scoring balloon is superior to the high pressure balloon in treating such lesions, so as to provide a basis for optimizing the treatment of such lesions. This study will be conducted in seven (7) clinical trial institutions, with a total of 140 subjects included. After randomization, the subjects will use either the scoring balloon dilatation catheter, developed and produced by DK Medical Technology Co., Ltd., or the peripheral balloon dilatation catheter for surgical treatment. Clinical follow-up will be carried out within 5 days, 3 months, 6 months, and 12 months after the procedure.
