Scoring Balloon and High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis

Official title

A Multicentre, Randomized Controlled Clinical Trial of Scoring Balloon Versus High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis

Overview

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.

Interventions

• Device 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.
• Device 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.

Primary outcome measures

• Target Lesion Primary Patency (TLPP) at 6 months post-procedure [Time frame: 6 months]

Secondary outcome measures (6)

• Target Lesion Primary Patency (TLPP) at 12 months post-procedure [Time frame: 12 months]
• Access Circuit Primary Patency (ACPP) at 6 and 12 months post-procedure [Time frame: 6, 12 months post-procedure]
• Access Circuit Secondary Patency (ACSP) 6 and 12 months after surgery [Time frame: 6, 12 months post-procedure]
• Acute Lumen Gain [Time frame: During the procedure]
• Technical Success [Time frame: 0-5 days post-procedure]
• Clinical Success [Time frame: 0-5 days post-procedure]

Eligibility criteria

Inclusion criteria

• Hemodialysis patients aged ≥18 and ≤80 years old, (Note: Hemodialysis patients in Singapore aged ≥ 21 and ≤80 years old);
• AVG is mature and has successfully completed at least one hemodialysis treatment;
• The target lesion is located in the AVG return vein and the venous side anastomosis;
• The degree of stenosis of the target lesion is ≥50% (DSA visual inspection), and one of the following clinical indicators exists at the same time: 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.
• The target lesion is primary or restenotic, consisting of one or more series of lesions, and the reference blood vessel diameter of the target lesion is between 4.0-8.0mm, and the total length of the target lesion is ≤80mm ;
• The patient voluntarily signs the informed consent form.

Exclusion criteria

• The target lesion is located in the feeding artery, arterial anastomosis, artificial blood vessel puncture site, cephalic venous arch, thoracic outlet or central vein;
• A stent has been implanted in any part of the access or there is ipsilateral central vein stenosis or occlusion that affects the function of the access;
• Severely calcified lesions that are not expected to be dilatable with balloons;
• Acute thrombosis or chronic total occlusion of AVG occurred at the time of enrolment;
• The target lesion or any part of the vascular access has received PTA treatment within the last month;
• There are thicker branch veins in the vein opening of the end-to-side anastomosis;
• Patients who have undergone major surgical treatment within 30 days before inclusion in the study;
• Patients known to be allergic to or intolerant to contrast media;
• Patients receiving glucocorticoids or immunosuppressants;
• The patient's life expectancy is less than 1 year;
• Patients planning kidney transplantation or switching to peritoneal dialysis;
• The degree of stenosis in the puncture point area is >50%；
• Patients with infection or other medical conditions that make the investigator think they are not suitable to participate in this study;
• Those who have participated in clinical trials of other drugs or devices but have not completed them.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 6 centers

• Beijing Tongren Hospital Affiliated to Capital Medical University — Beijing
• Guangdong Provincial People's Hospital — Guangzhou
• South China Hospital of Shenzhen University — Shenzhen
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou
• The Second Affiliated Hospital of Nanjing Medical University — Nanjing
• Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine — Shanghai

Singapore · 1 center

• National University Hospital of Singapore — Singapore

Identifiers

NCT: NCT06503692 · TR-0171

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗