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

Recruiting now

Conditions studied: Hemodialysis Access Failure

In brief

This study was aimed at evaluating the efficacy of different endovascular treatments for early and mid-stage clinical interventions in patients with autologous arteriovenous fistulae loss of function and the corresponding health economic value.

Key facts

Study ID

NCT06454396

Run by

RenJi Hospital

People needed

480

Starts

2023-01-01

Expected to finish

2026-12-31

Last updated by the study team

2024-06-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hemodialysis patients over 18 years of age and under 80 years of age
• Autologous arteriovenous fistula cannot be used in patients completing haemodialysis
• 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.
• Patients who have failed to open the initial target lesion and are successful on a second attempt at endoluminal therapy may still be enrolled.
• 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.

You may not qualify if…

• Planned kidney transplant or conversion to peritoneal dialysis
• Women who are pregnant, breastfeeding or planning to become pregnant during the study period
• Recent (within 30 days) or planned surgical procedure for haemodialysis access
• Allergy or contraindication to heparin, contrast media, antiplatelet drugs
• 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.
• Patients with a history of coagulation disorders or other haematological disorders
• 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.
• Patients unable or unwilling to participate in this trial

Where it is running

• Renji Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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