Effectiveness and Health Economics of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure

Launched by RENJI HOSPITAL · Jun 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying new ways to treat problems with hemodialysis access, specifically when an autologous arteriovenous fistula (a type of blood vessel connection used for dialysis) stops working properly. The goal is to find out how effective these treatments are and to evaluate their costs and benefits. The trial is currently looking for participants who are between 18 and 80 years old, are experiencing issues with their fistula, and have not had success in using it for dialysis. Participants will need to be able to understand the study and agree to be part of it.

If you join the trial, you can expect to receive specialized endovascular treatments aimed at fixing your fistula. You'll be followed up at specific times to monitor your progress. It’s important to note that certain people, including those planning for a kidney transplant or those with specific health conditions, may not be eligible to participate. Overall, this trial aims to improve treatment options for patients facing hemodialysis access failure and to gather important information about the economic impact of these treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Hemodialysis patients over 18 years of age and under 80 years of age
• • 2. Autologous arteriovenous fistula cannot be used in patients completing haemodialysis
• • 3. The guidewire must pass through at least the stenosis of the endovascular fistula on the side of the lesion and undergo further endovascular treatment before enrolment, and this study does not limit the form of the guidewire passing through the target lesion.
• • 4. Patients who have failed to open the initial target lesion and are successful on a second attempt at endoluminal therapy may still be enrolled.
• • 5. Subjects and their legal representatives are able to understand the purpose of the study, participate voluntarily and sign an informed consent form, and are willing to be followed up at specific points in time.
• 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