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
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to compare the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous stenosis of autologous arteriovenous fistulas.The main questions it aims to answer are: 1. Will drug-coated balloons achieve a better CD-TLR rate compared to cutting balloons? 2. What medical problems do participants have when receiving treatment with drug-coated balloons or cutting balloons?
CONDITIONS
Official 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 and have undergone at least one hemodialysis session
- Target lesion located in the venous segment of the upper limb AVF
- Doppler ultrasound confirms target lesion stenosis of 50% or more
- Presence of at least one clinical sign: elevated venous pressure during dialysis, abnormal fistula signs, or significant blood flow reduction (<200ml/min)
- Guidewire and balloon can pass through the lesion and complete dilation
- Understand the study purpose, voluntarily agree to participate, sign informed consent, and agree to follow-up schedules
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
- Diagnosed with symptomatic central venous occlusive disease confirmed by DSA
- Have two or more target lesions in the AVF less than 3 cm apart
- Acute thrombosis in the AVF or AVF thrombolysis/thrombectomy within past 30 days
- Surgical intervention on AVF within past 30 days or planned within 30 days
- AVF infection or systemic active infection
- Planning renal transplantation or switching to peritoneal dialysis within 12 months
- Diseases causing coagulopathy such as thrombocytopenic purpura
- Undergoing immunotherapy or suspected/diagnosed 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
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
CONTACT
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here