Actively Recruiting
Drug-coated Balloon Compared with Cutting Balloon in Treatment of Arteriovenous Fistula Stenosis
Led by RenJi Hospital · Updated on 2024-07-30
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 two types of balloon treatments—cutting balloons and drug-coated balloons—for venous stenosis in autologous arteriovenous fistulas used for hemodialysis. The study aims to determine whether drug-coated balloons offer better outcomes in terms of reducing the need for repeat procedures and to understand medical issues that may occur during treatment. The study will include 180 patients divided into two groups based on the treatment they receive: one group treated with cutting balloons and the other with drug-coated balloons. The treatments involve endovascular therapy, a minimally invasive procedure using catheters to access and treat the narrowed vein segments. The primary focus will be on patency rates and re-intervention rates at 1, 3, 6, and 12 months after the procedure, along with technical and procedural success and monitoring for major adverse events. Participants will be followed closely with evaluations at multiple time points to assess the condition of the treated arteries and veins. Researchers will track outcomes like the number of participants needing another procedure and how well the treated blood vessels remain open. The study will also monitor any complications during the perioperative period. The entire study will take place between June 2024 and December 2025, with follow-up assessments up to 12 months after treatment.
CONDITIONS
Brief Title
DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years
- Have a mature upper limb autologous arteriovenous fistula (AVF)
- Have undergone at least one hemodialysis session
- Target lesion located in the venous segment of the upper limb AVF with stenosis ≥50%
- Presence of at least one clinical sign: elevated venous pressure during dialysis, abnormal fistula signs, or blood flow less than 200 ml/min
- Guidewire and balloon can successfully pass through and dilate the lesion
- Understand the trial purpose, voluntarily consent to participate, and are willing to follow the study schedule
You will not qualify if you...
- Target lesion located in the arterial segment or anastomosis of the AVF
- Target lesion located in the lower limb AVF
- Previous stent implantation in the AVF
- Symptomatic central venous occlusive disease confirmed by DSA
- Two or more target lesions in the AVF with less than 3 cm between them
- Acute thrombosis in the AVF or thrombolysis/thrombectomy within the past 30 days
- Surgical intervention on the AVF within 30 days prior or planned within 30 days
- AVF infection or active systemic infection
- Planning renal transplantation or peritoneal dialysis within 12 months
- Diseases causing coagulopathy such as thrombocytopenic purpura
- Undergoing immunotherapy or suspected/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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with perioperative period
Participants undergo endovascular therapy treatment using either a drug-coated balloon or a cutting balloon to treat stenosis in their arteriovenous fistulas.
1 procedure visit and several perioperative assessments
Duration - 12 months
Participants are monitored for primary patency rates, re-intervention rates, and adverse events of the treated fistula over time.
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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