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Comparison of Drug-Coated Balloons and Cutting Balloons for Treating Autologous Arteriovenous Fistula Stenosis in a Multi-Center Prospective Study
Led by RenJi Hospital · Updated on 2024-07-09
180
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of cutting balloons compared to drug-coated balloons in treating venous segment stenosis in autologous arteriovenous fistulas. This prospective, multi-center cohort study aims to understand which treatment provides better outcomes for patients undergoing hemodialysis access failure. The study will enroll 180 patients between June 2024 and December 2025 across multiple centers. Participants will be divided into two groups based on the treatment they receive: one group treated with cutting balloons and the other with drug-coated balloons. Both treatments use endovascular therapy, a minimally invasive procedure that accesses the vascular system to treat the stenosis without open surgery. The study will track the success of these devices and monitor any major adverse events during and after the procedures. Throughout the study, patients will be followed up at 1, 3, 6, and 12 months after treatment to evaluate target lesion re-intervention rates, primary patency rates, and assisted primary patency rates of the treated vessels. Researchers will assess clinical success, monitor complications, and collect data on the technical and procedural success of each device. The total duration of participation will last up to 12 months after the intervention to ensure comprehensive outcome measurement.
CONDITIONS
Brief Title
Effectiveness of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years
- Have a mature upper limb autologous arteriovenous fistula
- Have undergone at least one hemodialysis session
- Target lesion located in the venous segment of the upper limb arteriovenous fistula
- Doppler ultrasound shows at least 50% stenosis with clinical signs like high venous pressure during dialysis or blood flow less than 200 ml/min
- Guidewire and balloon can successfully pass through and dilate the lesion
- Willing to participate voluntarily and follow the study schedule
You will not qualify if you...
- Target lesion in the arterial segment or anastomosis of the arteriovenous fistula
- Target lesion in the lower limb arteriovenous fistula
- Previous stent implantation in the arteriovenous fistula
- Symptomatic central venous occlusive disease confirmed by imaging
- Two or more target lesions in the arteriovenous fistula less than 3 cm apart
- Acute thrombosis or thrombolysis/thrombectomy within past 30 days
- Planned or recent surgical intervention on the fistula within 30 days
- Infection in the fistula or active systemic infection
- Planning renal transplant or peritoneal dialysis within 12 months
- Coagulopathy diseases like thrombocytopenic purpura
- Undergoing immunotherapy or diagnosed with vasculitis
- Allergies or contraindications to heparin or contrast agents
- Pregnant or breastfeeding
- Life expectancy less than 12 months
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive endovascular therapy to treat stenosis in their autologous arteriovenous fistula using either a cutting balloon or a drug-coated balloon.
1 procedure visit (in-person)
Duration - 12 months
Participants are monitored for primary patency rates and re-intervention needs of the target lesion at multiple time points after the procedure.
Visits at 1 month, 3 months, 6 months, and 12 months post-procedure
Trial Site Locations
Total: 3 locations
1
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
2
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
3
Renji Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
R
RuZhou Cao
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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