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

NCT06470646 | Recruiting DMC

• 1 other identifier: The AVG study
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

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 targetsite,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

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.

You may qualify if:

• Patients aged 18 to 80 years undergoing hemodialysis;
• Patients with arteriovenous graft fistula unable to complete hemodialysis;
• 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.

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

Study Officials

• JiaQuan Chen, M.M.

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cao Ruzhou

CONTACT

+86-18616752813; caorzh@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: September 1, 2023
• Primary Completion: May 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

CN (1)