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

NCT06454396 | Recruiting DMC

• 1 other identifier: The AVF study
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Access Failure

Outcome Measures

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.

  1-month；6-month；12-month；18-month；24-month

Secondary Outcomes (2)

• target lesion primary patency

  1-month；6-month；12-month；18-month；24-month

• target lesion assisted primary patency

  1-month；6-month；12-month；18-month；24-month

Interventions

Endovascular therapy PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.
• Patients with a history of coagulation disorders or other haematological disorders
• 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.
• Patients unable or unwilling to participate in this trial

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Central Study Contacts

Jingpu Zhu

CONTACT

+86-17520505530; a8600809@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

CN (1)