Effectiveness and Health Economics of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endovascular therapy.
- Who it may be relevant to
- Registry conditions: Hemodialysis Access Failure. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
This is a prospective, single-center, real-world study intended to understand the clinical intervention efficacy and health economic value of various real-world endovascular treatments for autologous arteriovenous endovascular fistulae failure in a target lesion defined as the hemodialysis access inflow tract (arterial, anastomotic, and inflection), intermediate segment, and outflow tract vein. The study will enroll 480 patients with autologous arteriovenous endovascular fistulae that have failed during the period 2023/1-2024/12, in a single center. They will be divided into subgroups according to different treatment modalities, such as balloon dilatation alone group, medicated balloon group, and stent implantation group. The main observations were the technical success rate of various endoluminal treatment methods, perioperative major adverse events, and symptom-driven target lesion re-intervention rate, target vessel patency rate, and total hospitalization expenditures related to the target lesion at 1, 6, 12, 18, and 24 months after the procedure.
Interventions
- Procedure Endovascular 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.
Primary outcome measures
- Clinically-driven target lesion re-intervention [Time frame: 1-month；6-month；12-month；18-month；24-month]
Secondary outcome measures (2)
- target lesion primary patency [Time frame: 1-month；6-month；12-month；18-month；24-month]
- target lesion assisted primary patency [Time frame: 1-month；6-month；12-month；18-month；24-month]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Renji Hospital — Shanghai
Identifiers
NCT: NCT06454396 · The AVF study