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

June 17, 2024 updated by: RenJi Hospital

A Real-World Clinical Study Based on Decentralized Arteriovenous Fistula Data System - Endovascular Treatment Efficacy and Health Economics Evaluation of Failure in Arteriovenous Graft Fistula.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. Study Population Patients with arteriovenous graft fistula failure.
  2. Sample Size Calculation This study is a prospective real-world study with few inclusion criteria and four subgroups, all compared pairwise. Under the premise of comparing two groups, this study uses the Logrank test to compare the differences in patient survival time. The expected primary patency rate for the control group is 6 months, and for the experimental group is up to 8 months. The trial requires at least 96 patients (48 in each group) to detect this difference with 90% power at a significance level of α=0.05 (two-sided). The study is planned for a recruitment period of 10 months and a follow-up period of 24 months, with an estimated dropout rate of 5% for both the experimental and control groups. Therefore, a total of 240 patients with arteriovenous graft fistula failure are planned to be recruited to meet the sample size requirements.
  3. Specific Research Content This study is a prospective, single-center real-world study aimed at understanding 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.
  4. Research Methods

1. Inclusion Criteria (Diagnostic Criteria, Inclusion Criteria, Exclusion Criteria)

Inclusion Criteria:

  1. Patients aged 18 to 80 years undergoing hemodialysis;
  2. Patients with arteriovenous graft fistula unable to complete hemodialysis;
  3. 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;
  4. Patients who have successfully undergone endovascular treatment again after the initial target lesion opening failure are still eligible for inclusion;
  5. 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.

Exclusion Criteria:

  1. Patients planning to undergo renal transplantation or switch to peritoneal dialysis;
  2. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
  3. Patients who have undergone or plan to undergo surgical treatment within the past 30 days of the study;
  4. Allergies or contraindications to heparin, contrast agents, or antiplatelet drugs.;
  5. Patients who have participated in interfering drug or other medical device clinical trials during the past 3 months;
  6. Patients with coagulation disorders or other hematologic diseases;
  7. Patients with other diseases that may cause trial difficulties or significantly shorten patient life expectancy (<2 years), such as tumors, severe liver disease, heart failure, etc., or patients with a life expectancy of less than 6 months;
  8. Patients unable or unwilling to participate in this trial.

2. Subject Allocation

This study adopts parallel grouping and is divided into multiple subgroups based on lesion treatment methods, totaling 240 cases:

Simple Balloon Dilation Group: Only using a regular balloon for dilation, without using other special balloons or stents.

Cutting Balloon Group: Using a cutting balloon for dilation, with the option of using a regular balloon for pre-dilation without using other special balloons or stents.

Drug-Coated Balloon Group: Using a drug-coated balloon for dilation, with the option of using a regular balloon/cutting balloon for pre-dilation without using a stent.

Stent Implantation Group: Implantation of stents, with the option of using a regular balloon/cutting balloon/drug-coated balloon for pre-dilation.

3. Trial Treatment All patients choose endovascular treatment methods. The approach is through the arterial end of the anastomosis, to open the target lesion, and in case of failure, considering retrograde puncture at the distal end of the venous stenosis for bidirectional opening. After the guidewire passes through the lesion, the operator can choose the treatment plan according to the characteristics of the lesion.

4. Subject Early Termination/Trial Termination Criteria

Subject Early Termination/Trial Termination Criteria:

  1. Withdrawal from the study due to adverse events, especially serious adverse events, based on safety and ethical considerations by the researchers;
  2. Loss to follow-up;
  3. Subject voluntarily withdraws informed consent;
  4. Serious violations of the trial protocol by the subject or researcher;
  5. Other situations deemed necessary for withdrawal

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Cao Ruzhou
  • Phone Number: +86-18616752813
  • Email: caorzh@126.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • RenJi Hospital
        • Contact:
        • Principal Investigator:
          • JiaQuan Chen, M.M.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  1. Patients aged 18 to 80 years undergoing hemodialysis;
  2. Patients with arteriovenous graft fistula unable to complete hemodialysis;
  3. 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;
  4. Patients who have successfully undergone endovascular treatment again after the initial target lesion opening failure are still eligible for inclusion;
  5. 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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinically-driven target lesion re-intervention
Time Frame: 1-month、6-month、12-month、18-month、24-month
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
target lesion primary patency
Time Frame: 1-month、6-month、12-month、18-month、24-month
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.
1-month、6-month、12-month、18-month、24-month
target lesion assisted primary patency
Time Frame: 1-month、6-month、12-month、18-month、24-month
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.
1-month、6-month、12-month、18-month、24-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RenJi Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: JiaQuan Chen, M.M., RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • The AVG study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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