Ireland
--:--IST
Recruiting Observational

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

NCT06454396 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2023-01-01
Last updated
2024-06-12

Condition(s) studied

Hemodialysis Access Failure

Investigational drug(s) / intervention(s)

Endovascular therapy

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 outcome measure(s)

  • Clinically-driven target lesion re-intervention — 1-month;6-month;12-month;18-month;24-month
    Clinically-driven target lesion re-intervention refers to a repeat procedure performed on a previously treated lesion due to the recurrence of symptoms or other clinical indications, rather than being routinely scheduled.

Trial sites (1)

FacilityCityRegionStatus
Renji Hospital Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06454396 on ClinicalTrials.gov ↗ ← All trials in China