Effectiveness and Health Economics of Endoluminal Treatment of Arteriovenous Graft Fistula.

Launched by RENJI HOSPITAL · Jun 17, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating different treatments for patients whose arteriovenous graft fistula—a type of access point used for hemodialysis—is not working properly. The goal is to see how effective various endovascular treatments, like balloon dilation and stent implantation, are in helping these patients continue their dialysis treatment. The study will involve 240 patients at a single center from September 2023 to December 2024. Researchers will look at things like how successful each treatment is, any complications that might occur, and the overall costs associated with these procedures over time.

To be eligible for this trial, participants must be between 18 and 80 years old, be undergoing hemodialysis, and have a graft fistula that is not functioning well enough for dialysis. They should also be able to undergo the necessary treatment procedures. However, individuals who are pregnant, planning to have a kidney transplant, or have certain medical conditions that could interfere with the study will not qualify. Participants can expect to be closely monitored for a couple of years after their treatment to help researchers gather important data on the effectiveness and safety of the different treatment methods.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged 18 to 80 years undergoing hemodialysis;
• • 2. Patients with arteriovenous graft fistula unable to complete hemodialysis;
• • 3. The guidewire must pass through the stenosis of the lesion side's graft fistula and further undergo endovascular treatment to be eligible for inclusion. This study does not limit the form of guidewire passing through the target lesion;
• • 4. Patients who have successfully undergone endovascular treatment again after the initial target lesion opening failure are still eligible for inclusion;
• • 5. Subjects and their legal representatives understand the purpose of the study, voluntarily participate, and sign informed consent forms, willing to undergo follow-up at specific time points in this trial.
• Exclusion Criteria:
• • 1. Planned kidney transplant or conversion to peritoneal dialysis
• • 2. Women who are pregnant,breastfeeding or planning to become pregnant during the study period
• • 3. Recent (within 30 days) or planned surgical procedure for haemodialysis access
• • 4. Allergy or contraindication to heparin, contrast media, antiplatelet drugs
• • 5. Patients who have participated in a clinical trial of a drug or other medical device that interferes with this clinical trial within the last 3 months.
• • 6. Patients with a history of coagulation disorders or other haematological disorders
• • 7. Patients with other conditions that may make the trial difficult or significantly shorten the patient's life expectancy (\<2 years), e.g.tumours,severe liver disease,cardiac insufficiency,etc.,or patients with a life expectancy of less than 6 months.
• • 8. Patients unable or unwilling to participate in this trial