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Scoring Balloon and High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis
Sponsor: DK Medical Technology (Suzhou) Co., Ltd.
Summary
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.
Official title: A Multicentre, Randomized Controlled Clinical Trial of Scoring Balloon Versus High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2024-08-13
Completion Date
2026-12
Last Updated
2025-01-09
Healthy Volunteers
No
Conditions
Interventions
DKutting PTA Scoring Balloon Dilatation Catheter
The device consists of a balloon catheter with scoring elements (triangular cross-section) fixed to the surface of the balloon and distributed radially at every 120°. When the balloon is inflated, the expansion force is focused along the scoring elements, causing it to expand under lower balloon pressure.
Peripheral Balloon Catheter
The device is an over-the-wire (OTW) double-lumen balloon catheter. The balloon is inflated to a known diameter at a specified pressure.
Locations (7)
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
South China Hospital of Shenzhen University
Shenzhen, Guangdong, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
National University Hospital of Singapore
Singapore, Singapore