Actively Recruiting
Endovascular Treatment Efficacy and Health Economics Evaluation for Failure in Arteriovenous Graft Fistula: A Real-World Clinical Study Based on Decentralized Data
Led by RenJi Hospital · Updated on 2024-06-24
240
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with arteriovenous graft fistula failure who require hemodialysis. This real-world, prospective study aims to evaluate the effects and health economic value of different endovascular treatment methods for this condition. The study focuses on lesions in the inflow tract, middle segment, and outflow vein of the dialysis pathway. A total of 240 patients will be recruited from a single center between September 2023 and December 2024 to compare various treatment approaches. Participants will receive different types of endovascular therapy, including simple balloon dilation, cutting balloon dilation, drug-coated balloon dilation, and stent implantation. Treatments are performed through the arterial end of the anastomosis to open the target lesion, with additional approaches if initial attempts fail. Patients are grouped based on the treatment method used, and treatments are selected according to the lesion's characteristics. During the study, patients will be monitored for technical success, major adverse events during the perioperative period, and symptom-driven re-intervention rates at 1, 6, 12, 18, and 24 months after treatment. Researchers will also track target vessel patency rates and total hospital costs related to the target lesions. Participants will provide informed consent and agree to follow-up visits at specific time points throughout the 24-month follow-up period.
CONDITIONS
Brief Title
Effectiveness and Health Economics of Endoluminal Treatment of Arteriovenous Graft Fistula.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years undergoing hemodialysis
- Patients with arteriovenous graft fistula unable to complete hemodialysis
- Guidewire passage through the stenosed graft fistula lesion and planned endovascular treatment
- Patients who have undergone endovascular treatment after initial target lesion opening failure
- Patients and their legal representatives who understand the study purpose, voluntarily participate, and sign informed consent, agreeing to follow-up
You will not qualify if you...
- Planned kidney transplant or switch to peritoneal dialysis
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- Recent or planned surgical procedure for hemodialysis access within 30 days
- Allergy or contraindication to heparin, contrast media, or antiplatelet drugs
- Participation in interfering drug or device clinical trials within the past 3 months
- History of coagulation or hematologic disorders
- Conditions causing trial difficulty or life expectancy under 2 years, including tumors, severe liver disease, or cardiac failure
- Life expectancy less than 6 months
- Unable or unwilling to participate in the trial
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 - Single procedure with immediate perioperative period
Participants undergo endovascular therapy to treat arteriovenous graft fistula failure using minimally invasive techniques through the vascular system.
1 procedure visit (in-person)
Duration - 24 months
Participants are monitored for clinical outcomes including re-intervention rates and vessel patency at multiple time points after treatment.
Follow-up visits at 1, 6, 12, 18, and 24 months post-treatment
Trial Site Locations
Total: 1 location
1
Renji Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
C
Cao Ruzhou
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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