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

Not Applicable

• Conditions: Uremia; Arteriovenous Fistula; Stenosis
• Interventions: Procedure: Surgical reconstruction; Device: DSA guided percutaneous balloon dilatation; Device: Ultrasound guided percutaneous balloon dilatation

• Registration Number: NCT02266238
• Lead Sponsor: Shanghai Changzheng Hospital

Brief Summary

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

Eligibility Criteria:

1. Patients with long-term maintenance hemodialysis with AVF as the vascular access;

2. 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.

3. Doppler ultrasound /DSA/magnetic resonance angiography show the diameter of AVF fistula is \>50% narrow than the adjacent segment of the fistula lumen.

4. Blood flow of the AVF is \<500ml/min or monthly declines of the blood flow\>25%.

5. Patient signed the informed consent.

Study Timeline

• Study First Submitted: 2014-09-22
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-12
• Last Update Submitted: 2014-10-12
• Study First Posted: 2014-10-16
• Last Update Posted: 2014-10-16
• Study Start: 2015-01
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1. Patients with long-term maintenance hemodialysis with AVF as the vascular access;
2. 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;
3. Doppler ultrasound /DSA/MRA show the diameter of AVF fistula is >50% narrow than the adjacent segment of the fistula lumen;
4. Blood flow of the AVF is <500ml/min or monthly declines of the blood flow>25%;
5. Patient signed the informed consent.

Exclusion Criteria

1. allergic to the iodine contrast or gadolinium contrast agent;
2. local infection;
3. the presence of severe coagulation dysfunction (or long-term history of taking warfarin or ticlopidine);
4. the presence of severe artery steal syndrome;
5. stenosis of immature fistula or fistula <2 month after vascular anastomosis;
6. severe central venous stenosis;
7. discontinue hemodialysis treatment (such as to transfer to peritoneal dialysis or kidney transplant);
8. 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;
9. participated in other clinical trials within 12 weeks;
10. alcohol and/or drug abusers, mental disorders;
11. patients not suitable as the subjects of this trial under the consideration of researchers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3	Surgical reconstruction	Surgical reconstruction of the stenosis to reconstruction the lumen of arteriovenous fistula
Group 1	DSA guided percutaneous balloon dilatation	DSA guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula
Group 2	Ultrasound guided percutaneous balloon dilatation	Ultrasound guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula

Primary Outcome Measures

Name	Time	Method
the patency rate of the AVF after intervention	24 month	the patency rate including the primary and the secondary patency rate

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, China