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To evaluate the efficacy and safety of ultrasound-guided percutaneous balloon dilation (PTA) with domestic high-pressure balloon dilatation catheter in the treatment of arteriovenous fistula stenosis in hemodialysis patients, a prospective, multi-center, single-group objective clinical study

To evaluate the efficacy and safety of ultrasound-guided percutaneous balloon dilation (PTA) with domestic high-pressure balloon dilatation catheter in the treatment of arteriovenous fistula stenosis in hemodialysis patients, a prospective, multi-center, single-group objective clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094447
Enrollment
Unknown
Registered
2024-12-23
Start date
2023-03-14
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Arteriovenous fistula stenosis

Interventions

Experimental Group:The stenosis site of arteriovenous fistula was dilated by percutaneous balloon under ultrasound

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients treated with stable dialysis for arteriovenous fistula; 2.Older than 18 years old, regardless of gender; 3.Color Doppler angiography showed local stenosis exceeding 50% of the normal vascular diameter accompanied by one of the following conditions: Natural blood flow of internal fistula < 500ml/min; The blood flow during dialysis was less than 200ml/min, and different degrees of puncture difficulty could not meet the demand of dialysis blood flow; The internal fistula tremor became smaller or disappeared, and the originally filled veins collapsed; 4.Participate in clinical research voluntarily and sign informed consent.

Exclusion criteria

Exclusion criteria: 1.History of PTA operation at the same internal fistula site; 2. Severe coagulation disorder (INR > 2.5 or platelet < 50×109/L); 3.Severe systemic infection, sepsis and sepsis are not effectively controlled; 4. Poor internal fistula flow due to large opening of nearby collateral vessels; 5. Patients with mental illness or history of mental illness; 6. Pregnant women, lactating patients and patients who have planned to give birth recently; 7. The investigator evaluated patients who could not participate in the clinical study.

Design outcomes

Primary

MeasureTime frame
Success rate of PTA;

Secondary

MeasureTime frame
Primary patency time;Primary patency rate at 1, 3 and 6 months after PTA;Performance index;

Countries

China

Contacts

Public ContactYan Yan

The First Affiliated Hospital of Nanchang University

kiddoc@163.com+86 180 0071 9336

Outcome results

None listed

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