Skip to content

Pragmatic Randomized Controlled Trial of Scoring Balloon versus High-Pressure Balloon for Dysfunctional Graft Arteriovenous Fistulas

Pragmatic Randomized Controlled Trial of Scoring Balloon versus High-Pressure Balloon for Dysfunctional Graft Arteriovenous Fistulas

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107732
Enrollment
Unknown
Registered
2025-08-18
Start date
2025-08-31
Completion date
Unknown
Last updated
2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arteriovenous graft nonfunction

Interventions

scoring balloon group:scoring balloon PTA
high pressure balloon group:high pressure balloon PTA

Sponsors

Beijing Haidian Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Hemodialysis patients with age >=18 years old and 50%, and one of the following clinical symptoms or indicators is present at the same time: significant increase in venous pressure during dialysis, abnormal physical examination, decreased pump-controlled blood flow, decreased dialysis adequacy, brachial artery blood flow < 600ml/min or decreased by 25% compared with the previous follow-up; 5. Stenotic lesions are primary or restenosis, consisting of one or more tandem lesions, and the reference vessel diameter of the target lesion is between 4.0-8.0mm, and the total length of the target lesion is <=80mm; 6. If there is a thrombosis, the thrombus spreads to the autologous vein < length of 10cm and there is no obvious tumor-like expansion of the autologous vein; 7. Patients voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Stenotic lesion located in the feeding artery, arterial anastomosis, cephalic arch, thoracic outlet, or central vein. 2.Any stent previously implanted anywhere in the access circuit or the presence of ipsilateral central vein stenosis or occlusion affecting access function. 3.Severely calcified lesion anticipated to be non-dilatable with a balloon. 4.Chronic total occlusion (CTO) of the AVG at the time of enrollment. 5.Stenotic lesion or any part of the vascular access has undergone percutaneous transluminal angioplasty (PTA) treatment within the past month. 6.Presence of a significant accessory vein at the venous ostium of an end-to-side anastomosis. 7.Patient has undergone major surgical treatment within 30 days prior to enrollment. 8.Patient is currently receiving corticosteroid or immunosuppressive therapy. 9.Patient has a life expectancy of less than 1 year. 10.Patient is scheduled for a kidney transplant or plans to switch to peritoneal dialysis. 11.Patient has other medical conditions (e.g., active infection) that, in the investigator's judgment, make participation in this study unsuitable.

Design outcomes

Primary

MeasureTime frame
Postoperative 6-month primary patency rate of the access;

Countries

China

Contacts

Public ContactLihong Zhang

Beijing Haidian Hospital

zhanglihongzhu@163.com+86 10 82693132

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026