Clinical trial NCT06454396: Effectiveness and Health Economics of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemodialysis Access Failure
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dysfunctional autogenous arteriovenous fistula patient:

A stenosis in a hemodialysis access with significant hemodynamic changes: Based on angiography/ultrasound evaluation, the target lesion stenosis is ≥50%, and is accompanied by one or more of the following clinical and physiological abnormalities: natural fistula blood flow \<480ml/min; unable to meet the required blood flow for the dialysis prescription; thrombosis in the autogenous arteriovenous fistula; elevated venous pressure during dialysis; difficult cannulation; decreased dialysis adequacy; and abnormal signs in the fistula, etc.

Brief 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.

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.

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

Primary outcomes:
measure: Clinically-driven target lesion re-intervention
timeFrame: 1-month；6-month；12-month；18-month；24-month
Secondary outcomes:
measure: target lesion primary patency
timeFrame: 1-month；6-month；12-month；18-month；24-month
measure: target lesion assisted primary patency
timeFrame: 1-month；6-month；12-month；18-month；24-month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
References: