Scoring Balloon and High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis
NCT Number: NCT06503692
Acronym: DKTAVG
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Arteriovenous Graft Stenosis
Interventions: DEVICE: DKutting PTA Scoring Balloon Dilatation Catheter|DEVICE: Peripheral Balloon Catheter
Sponsor: DK Medical Technology (Suzhou) Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-12
Locations: Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing, Beijing, 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, China|National University Hospital of Singapore, Singapore, Singapore

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.

Primary Outcome Measures: Target Lesion Primary Patency (TLPP) at 6 months post-procedure, TLPP is terminated by postoperative target lesion failure (TLF) (including the 5 mm range before and after the target lesion) or target lesion-related vascular access thrombosis.

TLF is defined as the presence of at least one clinical indicator (defined according to the NKF-K/DOQI guidelines) caused by target lesion stenosis ( ≥50% stenosis of the target lesion assessed by contrast angiography or ultrasound), including physical examination abnormalities or dialysis abnormalities.

Target lesion-related vascular access thrombosis is limited to: after the thrombus is removed during AVG thrombus treatment and before balloon dilatation, it is confirmed by ultrasound/DSA that the original target lesion has a stenosis ≥ 50%, or when the balloon is expanded with low pressure (\<6 atm) during intraluminal treatment, obvious balloon residual waisting can be seen at the target lesion; simple mural thrombus at the puncture point or other parts of the graft needs to be ruled out., 6 months
Secondary Outcome Measures: Target Lesion Primary Patency (TLPP) at 12 months post-procedure, TLPP is terminated by postoperative target lesion failure (TLF) (including the 5 mm range before and after the target lesion) or target lesion-related vascular access thrombosis.

TLF is defined as the presence of at least one clinical indicator (defined according to the NKF-K/DOQI guidelines) caused by target lesion stenosis ( ≥50% stenosis of the target lesion assessed by contrast angiography or ultrasound), including physical examination abnormalities or dialysis abnormalities.

Target lesion-related vascular access thrombosis is limited to: after the thrombus is removed during AVG thrombus treatment and before balloon dilatation, it is confirmed by ultrasound/DSA that the original target lesion has a stenosis ≥ 50%, or when the balloon is expanded with low pressure (\<6 atm) during intraluminal treatment, obvious balloon residual waisting can be seen at the target lesion; simple mural thrombus at the puncture point or other parts of the graft needs to be ruled out., 12 months|Access Circuit Primary Patency (ACPP) at 6 and 12 months post-procedure, ACPP is terminated when stenosis or thrombus causing abnormal clinical indicators occurs in any part of the AVG after surgery (inflow artery, entire graft, and outflow vein, including central vein). (Definition according to NKF- K/DOQI guidelines), including physical examination abnormalities or dialysis abnormalities. Physical examination abnormalities include: open collateral veins, ipsilateral limb edema, changes in pulse characteristics, abnormal tremors, abnormal murmurs, etc.; Dialysis abnormalities include: increased venous pressure, new puncture difficulties, aspiration of thrombi, inability to reach target dialysis blood flow, prolonged haemostasis time after needle removal for 3 consecutive times, unexplained decrease in dialysis dose Kt/V (\>0.2 units), decrease in brachial artery blood flow (brachial artery blood flow \<650ml/min or decreased by 20% compared with the previous follow-up visit), etc., 6, 12 months post-procedure|Access Circuit Secondary Patency (ACSP) 6 and 12 months after surgery, ACSP terminates when the AVG is abandoned due to various reasons after surgery, during which multiple interventions can be performed to maintain the patency of the entire pathway., 6, 12 months post-procedure|Acute Lumen Gain, Immediately after dilation, DSA uses two different angles (≥45°) for angiography (a unified x-ray ruler will be provided as the reference object to reduce measurement errors) Calculation formula: minimum lumen diameter of the target lesion immediately after dilation - minimum lumen diameter of the target lesion before procedure., During the procedure|Technical Success, Residual stenosis of the target lesion after surgery is ≤30%, and no serious adverse events related to the investigational device occurred during the perioperative period., 0-5 days post-procedure|Clinical Success, Complete at least one successful hemodialysis session after surgery, 0-5 days post-procedure