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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorRenJi Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Endovascular therapy

    Procedure/Surgery

    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.

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-month

Secondary outcomes

1

target lesion primary patency

Target lesion primary patency refers to the treated lesion site remaining open and unobstructed without the need for any additional revascularization procedure during the follow-up period.

Time frame
1-month;6-month;12-month;18-month;24-month
2

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-month

Other outcomes

Sponsors and contacts

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