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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
168
Procedure: Percutaneous Transluminal Angiography, Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Zhengzhou University
Technical Success
The target lesion residual stenosis\<30%
Time frame: Right after operation
Device Success
During the operation, Balloon dilatation catheters can be delivered to the target lesion, inflated≤RBP without rupture and withdrawed successfully
Time frame: Right after operation
Procedural Success
Base on the technical success, without MAE including death, thrombosis, allergic reactions, pulmonary diseases (pulmonary edema)
Time frame: 12-48 hours
Dilating Pressure
The minimum pressure with which the balloon can be completely inflated without waist during the operation
Time frame: During the operation
Pain Score
The pain during dilating procedure, measured by NRS (increase from 0 to 10)
Time frame: Right after operation
Target Lesion Primary Patency (TLPP)
Defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. TLPP ends with a clinically driven re-intervention of the target lesion or access thrombosis.
Time frame: 1 month
Target lesion restenosis
Target lesion diameter restenosis rate(measured by DUS)=100%\*(1-(MLD/RVD)) (MLD includes 5mm range of proximal and distal of targer lesions
Time frame: 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Zhengzhou, Henan, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhengjiang, China
Fistula Blood Flow
Measured Brachial artery blood flow of arteriovenous fistula flow assessed by DUS.
Time frame: 1 month
Adverse Events
Number of device and procedure related adverse events (CEC Adjudicated)
Time frame: 1 month