Comparing drug-coated balloons and cutting balloons for treating arteriovenous fistula stenosis
DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis
This study is testing whether drug-coated balloons or cutting balloons work better and are safer for treating narrowing in arteriovenous fistulas in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 3 sites (Zhengzhou, Henan and 2 other locations) |
| Trial ID | NCT06527963 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the efficacy and safety of drug-coated balloons versus cutting balloons in treating venous stenosis of autologous arteriovenous fistulas. It will recruit 180 patients across multiple centers from June 2024 to December 2025, dividing them into two groups based on the treatment method. The study will assess primary patency rates, re-intervention rates, and major adverse events during the perioperative period to determine which balloon type is more effective. Participants will be monitored at 1, 3, 6, and 12 months post-operation.
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 confirmed by Doppler ultrasound.
Not a fit: Patients with stenosis located in the arterial segment or anastomosis of the AVF, or those with lower limb AVFs, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with arteriovenous fistula stenosis, potentially enhancing their hemodialysis access and outcomes.
How similar studies have performed: Previous studies have shown varying success with balloon interventions in vascular treatments, but this specific comparison of drug-coated versus cutting balloons is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects aged between 18 and 75 years. Subjects possess a mature upper limb autologous arteriovenous fistula (AVF) and have undergone at least one hemodialysis session. Target lesion must be located in the venous segment of the upper limb AVF. 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). 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: Target lesion located in the arterial segment or anastomosis of the AVF. Target lesion located in the lower limb AVF. Subjects with previous stent implantation in the AVF. 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. 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). Subjects with acute thrombosis in the AVF or who have undergone AVF thrombolysis or thrombectomy within the past 30 days. Subjects who have undergone or plan to undergo surgical intervention on the AVF within 30 days. Subjects with AVF infection or concurrent systemic active infection. Subjects planning renal transplantation or switching to peritoneal dialysis within the next 12 months. Subjects with diseases causing coagulopathy, such as thrombocytopenic purpura. Subjects undergoing immunotherapy or suspected/diagnosed with vasculitis. Subjects with allergies or contraindications to heparin or contrast agents. Subjects who are pregnant or breastfeeding. 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
- Email: caorzh@126.com
- Phone: +86 18616752813
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.