Effectiveness and Health Economics of Endoluminal Treatment of Arteriovenous Graft Fistula.
ConditionHemodialysis Access Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorRenJi Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 to 80 years undergoing hemodialysis;
Patients with arteriovenous graft fistula unable to complete hemodialysis;
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;
Patients who have successfully undergone endovascular treatment again after the initial target lesion opening failure are still eligible for inclusion;
Disqualifiers
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
Trial population
Hemodialysis access stenosis with significant hemodynamic changes: Evaluated by ultrasound, the target lesion PSVR ≤ 2.0, accompanied by one or more of the following clinical and physiological abnormalities: natural blood flow of the fistula \<500ml/min; inability to meet the blood flow required by the dialysis prescription; thrombosis formation in arteriovenous graft fistula; elevated venous pressure during dialysis; difficulty in puncture; decline in dialysis adequacy; and abnormal signs of the fistula, etc.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Endovascular therapy
Procedure/SurgeryEndovascular 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Clinically-driven target lesion re-intervention
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.
Time frame
1-month、6-month、12-month、18-month、24-monthSecondary outcomes
1
target lesion primary patency
Target lesion primary patency refers to the treated lesion site remaining open and unobstructed without the needfor any additional revascularization procedure during the follow-up period.
Time frame
1-month、6-month、12-month、18-month、24-month2
target lesion assisted primary patency
Target lesion assisted primary patency refers to the treated lesion site remaining patent(open) during the follow-up period,but requiring an additional revascularization procedure,such as percutaneous transluminal angioplasty,to maintain patency of the target lesion.
Time frame
1-month、6-month、12-month、18-month、24-monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov