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

NCT ID: NCT06454396

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 480 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2026-12-31

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.

Detailed Description

This is a prospective, single-center, real-world study intended to understand the clinical intervention efficacy and health economic value of various real-world endovascular treatments for autologous arteriovenous endovascular fistulae failure in a target lesion defined as the hemodialysis access inflow tract (arterial, anastomotic, and inflection), intermediate segment, and outflow tract vein. The study will enroll 480 patients with autologous arteriovenous endovascular fistulae that have failed during the period 2023/1-2024/12, in a single center. They will be divided into subgroups according to different treatment modalities, such as balloon dilatation alone group, medicated balloon group, and stent implantation group. The main observations were the technical success rate of various endoluminal treatment methods, perioperative major adverse events, and symptom-driven target lesion re-intervention rate, target vessel patency rate, and total hospitalization expenditures related to the target lesion at 1, 6, 12, 18, and 24 months after the procedure.

Conditions

Hemodialysis Access Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jingpu Zhu

Role: CONTACT

a8600809@163.com

+86-17520505530

Facility Contacts

Jingpu Zhu

Role: primary

+86-17520505530

Other Identifiers

The AVF study

Identifier Type: -

Identifier Source: org_study_id