Stenosis of Arteria-Venous Fistula in Maintenance Hemodialysis Patients: Early Intervention Trial

Study Overview
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Brief Summary
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The purpose of this study is to compare the effect of DSA guided percutaneous balloon dilatation, ultrasound guided percutaneous balloon dilatation and surgical repair in the treatment of Stenosis of Arteria-Venous Fistula in Maintenance Hemodialysis Patients.

Detailed Description
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Eligibility Criteria: Patients with long-term maintenance hemodialysis with AVF as the vascular access; Positive clinical examination signs of AVF stenosis （not all required） : (1) the visual examination: edema, prolonged bleeding time, hematoma, aneurysm or constriction of the fistula .(2) the palpation examination: a narrowing of the outflow vein or aneurysm formation. (3) the auscultation examination: high pitch and/or discontinuous murmur. Doppler ultrasound /DSA/magnetic resonance angiography show the diameter of AVF fistula is >50% narrow than the adjacent segment of the fistula lumen. Blood flow of the AVF is <500ml/min or monthly declines of the blood flow>25%. Patient signed the informed consent.

Official Title
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Randomized Controlled Trial to Compare Therapeutic Effect of Digital Subtraction Angiography(DSA)，Ultrasound Guided Balloon Dilatation and Surgical Reconstruction in Arteria-venous Fistula(AVF) Stenosis in Maintenance Hemodialysis Patients

Conditions
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Arteriovenous Fistula, Stenosis, Uremia

Intervention / Treatment
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* Device: DSA guided percutaneous balloon dilatation
* Device: Ultrasound guided percutaneous balloon dilatation
* Procedure: Surgical reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with long-term maintenance hemodialysis with AVF as the vascular access; Positive clinical examination signs of AVF stenosis （not all required） : (1) the visual examination: edema, prolonged bleeding time, hematoma, aneurysm or constriction of the fistula .(2) the palpation examination: a narrowing of the outflow vein or aneurysm formation. (3) the auscultation examination: high pitch and/or discontinuous murmur; Doppler ultrasound /DSA/MRA show the diameter of AVF fistula is >50% narrow than the adjacent segment of the fistula lumen; Blood flow of the AVF is <500ml/min or monthly declines of the blood flow>25%; Patient signed the informed consent. Exclusion Criteria: allergic to the iodine contrast or gadolinium contrast agent; local infection; the presence of severe coagulation dysfunction (or long-term history of taking warfarin or ticlopidine); the presence of severe artery steal syndrome; stenosis of immature fistula or fistula <2 month after vascular anastomosis; severe central venous stenosis; discontinue hemodialysis treatment (such as to transfer to peritoneal dialysis or kidney transplant); severe cardiac dysfunction (New York Heart Association cardiac functional classification III or worse), unstable angina pectoris, myocardial infarction, severe left ventricular hypertrophy, or severe vascular embolic disease; participated in other clinical trials within 12 weeks; alcohol and/or drug abusers, mental disorders; patients not suitable as the subjects of this trial under the consideration of researchers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>DSA guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula | Device: DSA guided percutaneous balloon dilatation<br>* Under the guidance of DSA, balloon is introduced into the stenosis area, proper pressure is given to achieve balloon dilatation to expand the narrow AVF lumen.<br>|
| Experimental: Group 2<br>Ultrasound guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula | Device: Ultrasound guided percutaneous balloon dilatation<br>* Under the guidance of ultrasound, balloon is introduced into the stenosis area, proper pressure is given to achieve balloon dilatation to expand the narrow AVF lumen.<br>|
| Experimental: Group 3<br>Surgical reconstruction of the stenosis to reconstruction the lumen of arteriovenous fistula | Procedure: Surgical reconstruction<br>* Direct surgery to reconstruction the AVF lumen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the patency rate of the AVF after intervention | the patency rate including the primary and the secondary patency rate | 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of AVF stenosis interventions | Described as %. | 24 month | 
| The recurrence rate of AVF stenosis interventions | Described as %. | 24 month | 
| The side effects of AVF stenosis interventions | Described as %.Side effects including bleeding, infection, thrombosis, artery steal syndrome, heart failure, inadequate dialysis, etc. | 24 month | 
| The cost-effectiveness analysis of AVF stenosis interventions | Described as $. | 24 month |