Comparing cutting balloons and drug-coated balloons for treating fistula failure

Comparison of the Efficacy of Drug-Coated Balloons and Cutting Balloons in the Treatment of Autologous Arteriovenous Fistula Stenosis: A Multi-Center Prospective Real-World Study.

This study is testing whether cutting balloons or drug-coated balloons work better for treating problems in arteriovenous fistulas in patients with venous segment stenosis.

Quick facts

• Study type: Observational
• Enrollment: 180 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: RenJi Hospital (other)
• Drugs / interventions: immunotherapy
• Locations: 3 sites (Zhengzhou, Henan and 2 other locations)
• Trial ID: NCT06493292 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness and safety of two different balloon treatments—cutting balloons and drug-coated balloons—in patients with venous segment stenosis of autologous arteriovenous fistulas. A total of 180 patients will be recruited across multiple centers from June 2024 to December 2025. Participants will be divided into two groups based on the treatment method, and the study will assess primary patency rates, re-intervention rates, and procedural success rates at various time points post-operation. Additionally, major adverse events during the perioperative period will be monitored.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a mature upper limb autologous arteriovenous fistula and significant venous stenosis.

Not a fit: Patients with lesions located in the arterial segment or anastomosis of the AVF will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment options for patients experiencing hemodialysis access failure.

How similar studies have performed: Other studies have shown promise in using balloon therapies for similar conditions, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Subjects aged between 18 and 75 years.
2. Subjects possess a mature upper limb autologous arteriovenous fistula (AVF) and have undergone at least one hemodialysis session.
3. Target lesion must be located in the venous segment of the upper limb AVF.
4. Doppler ultrasound confirms that the target lesion stenosis is ≥50%, accompanied by at least one of the following clinical manifestations: elevated venous pressure during dialysis, abnormal fistula signs, significant reduction in blood flow (\<200ml/min).
5. Guidewire and balloon successfully pass through the lesion and complete dilation. 6.Subjects or their legal representatives must understand the purpose of the trial, voluntarily participate in the clinical trial, and sign an informed consent form, while also being willing to adhere to the specific follow-up schedules set by this trial.

Exclusion Criteria:

1. Target lesion located in the arterial segment or anastomosis of the AVF.
2. Target lesion located in the lower limb AVF.
3. Subjects with previous stent implantation in the AVF.
4. Patients diagnosed with symptomatic central venous occlusive disease: AVF flow reduction accompanied by swelling of the ipsilateral limb, chest, or facial area, with DSA confirmation of central venous occlusive disease.
5. Subjects with two or more target lesions in the AVF (when two stenoses are less than 3 cm apart, they are considered as one target lesion).
6. Subjects with acute thrombosis in the AVF or who have undergone AVF thrombolysis or thrombectomy within the past 30 days.
7. Subjects who have undergone or plan to undergo surgical intervention on the AVF within 30 days.
8. Subjects with AVF infection or concurrent systemic active infection.
9. Subjects planning renal transplantation or switching to peritoneal dialysis within the next 12 months.
10. Subjects with diseases causing coagulopathy, such as thrombocytopenic purpura.
11. Subjects undergoing immunotherapy or suspected/diagnosed with vasculitis.
12. Subjects with allergies or contraindications to heparin or contrast agents.
13. Subjects who are pregnant or breastfeeding.
14. Subjects with a life expectancy of less than 12 months.

Where this trial is running

Zhengzhou, Henan and 2 other locations

• First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)
• The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)
• Renji Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Lan Zhang — Shanghai Jiao Tong University School of Medicine，Renji Hospital
• Study coordinator: RuZhou Cao

Conditions: Hemodialysis Access Failure