RecruitingNCT06454396

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

A Real-world Clinical Study Based on a Decentralized Arteriovenous Endovascular Fistula Data System - Effectiveness and Health Economics of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure

Sponsor

RenJi Hospital

Enrollment

480 participants

Start Date

Jan 1, 2023

Study Type

OBSERVATIONAL

Conditions

Hemodialysis Access Failure

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

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.

Exclusion Criteria8

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

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Interventions

PROCEDUREEndovascular therapy

Endovascular therapy is a minimally invasive interventional approach that utilizes the vascular system as a pathway to access and treat various pathological conditions within the body. By employing specialized catheters and devices, endovascular techniques enable precise delivery of therapeutic agents or interventional procedures directly to the target site, without the need for conventional open surgery.