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Clinical Trials in China / NCT06470646
Recruiting Observational

Effectiveness and Health Economics of Endoluminal Treatment of Arteriovenous Graft Fistula.

NCT06470646 · tracked via the Priya Life Science China tracker
Sponsor
RenJi Hospital
Phase
Observational
Started
2023-09-01
Last updated
2024-06-24

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 targetsite,without the need for conventional open surgery.

Study summary

This study is a prospective, single-center real-world research, aiming to understand the clinical intervention effects and health economics value of various endovascular treatment methods for arteriovenous graft fistula failure in the real world. The target lesion is defined as the inflow tract (artery, anastomosis, bend), middle segment, and outflow vein of the dialysis pathway. The study will recruit 240 patients with arteriovenous graft fistula failure at a single center from September 2023 to December 2024. Depending on different treatment methods, patients will be divided into several subgroups, such as the simple balloon dilation group, drug balloon group, stent implantation group, etc. As this is a real-world study, the main observations will be the technical success rate of various endovascular treatment methods, major adverse events during the perioperative period, and the symptom-driven target lesion re-intervention rate, target vessel patency rate, and total hospital expenditure related to target lesions at 1, 6, 12, 18, and 24 months postoperatively.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients aged 18 to 80 years undergoing hemodialysis; 2. Patients with arteriovenous graft fistula unable to complete hemodialysis; 3. The guidewire must pass through the stenosis of the lesion side's graft fistula and further undergo endovascular treatment to be eligible for inclusion. This study does not limit the form of guidewire passing through the target lesion; 4. Patients who have successfully undergone endovascular treatment again after the initial target lesion opening failure are still eligible for inclusion; 5. Subjects and their legal representatives understand the purpose of the study, voluntarily participate, and sign informed consent forms, willing to undergo follow-up at specific time points in this trial. 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

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Other trials for the same condition

Effectiveness of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure Recruiting
DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis Recruiting
Effectiveness and Health Economics of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure 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 NCT06470646 on ClinicalTrials.gov ↗ ← All trials in China