Actively Recruiting
Effectiveness of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure
Led by RenJi Hospital · Updated on 2024-07-09
180
Participants Needed
3
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was aimed at comparing the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous segment stenosis of autologous arteriovenous fistulas.This is a prospective, multi-center cohort study.
CONDITIONS
Official Title
Effectiveness of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 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 arteriovenous fistula
- Doppler ultrasound confirms at least 50% narrowing in the target lesion with clinical signs such as elevated venous pressure during dialysis, abnormal fistula signs, or blood flow below 200 ml/min
- Guidewire and balloon can successfully pass through the lesion and complete dilation
- Willingness to understand the study purpose, voluntarily participate, sign informed consent, and adhere to follow-up schedules
You will not qualify if you...
- Target lesion located in the arterial segment or anastomosis of the arteriovenous fistula
- Target lesion located in the lower limb arteriovenous fistula
- Previous stent implantation in the arteriovenous fistula
- Symptomatic central venous occlusive disease confirmed by DSA with related symptoms
- Two or more target lesions in the arteriovenous fistula (less than 3 cm apart considered one lesion)
- Acute thrombosis in the fistula or thrombolysis/thrombectomy within the past 30 days
- Surgical intervention on the fistula within 30 days before or planned within 30 days after enrollment
- Arteriovenous fistula 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 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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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
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