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Evaluation of the efficacy of stepwise balloon dilatation in the treatment of autologous arteriovenous fistula stenosis

Evaluation of the efficacy of stepwise balloon dilatation in the treatment of autologous arteriovenous fistula stenosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091424
Enrollment
Unknown
Registered
2024-10-28
Start date
2023-02-09
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

Hemodialysis

Interventions

experimental group :Stepped balloon diameter expansion was used for radioactive brachiocephalic autogenous arteriovenous fistula that met the stenosis criteria.
control group:Radioactive brachiocephalic autogenous arteriovenous fistulas that meet the stenosis criteria were dilated with a universal diameter balloon.

Sponsors

Department of Nephrology, Shanxi Bethune Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-80 years old. (2) All of them were mature RCAVF and stenosis at least 3 times.(3) All patients with type I stenosis (stenosis occurring at arteriovenous anastomosis and within 2cm of anastomosis) were selected. (4) It is consistent with the AVF stenosis intervention indication in the Expert Consensus on Vascular Access for hemodialysis in China (2nd edition) (The local stenosis rate exceeding 50% of nearby normal vascular diameter accompanied by the following conditions: internal fistula natural blood flow < 500mL/min; Can not meet the blood flow required for dialysis; Increased dialysis venous pressure; Puncture difficulty; Decreased dialysis adequacy; And abnormal signs of internal fistula (decreased or disappeared anastomotic tremor, high distal venous tension, pulsation, etc.).

Exclusion criteria

Exclusion criteria: (1) Patients with heart function grade IV, left ventricular ejection fraction less than 30%, and serious dysfunction of heart and brain and other important organs. (2) Malignant tumors. (3) Severe liver disease. (4) Internal fistula infection. (5) Patients with vascular disease and vascular variation before surgery. (6) The application of drug balloons, cutting balloons or other special types of balloons. (7) Patients with mental abnormalities and cognitive disorders who are unable to cooperate.

Design outcomes

Primary

MeasureTime frame
target lesion primary patency;target assisted primary patency;target lesion secondary patency;brachial artery blood flow;stenosis diameter;

Secondary

MeasureTime frame
technical success rate;clinical success rate;major complications;risk factors affecting patency of target lesions;

Countries

China

Contacts

Public ContactXiaoguang Huang

Shanxi Bethune Hospital,Shanxi Academy of Medical Sciences

hxg5534@163.com+86 130 9664 7864

Outcome results

None listed

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