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

Naval Military Medical University (Second Military Medical University)

Status: Unknown

Conditions: Uremia; Arteriovenous Fistula; Stenosis

Treatments: Device: Ultrasound guided percutaneous balloon dilatation; Device: DSA guided percutaneous balloon dilatation; Procedure: Surgical reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT02266238

CZHKI-HDVA-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 3 patient groups

Group 1

Experimental group

Description:

DSA guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula

Treatment:

Device: DSA guided percutaneous balloon dilatation

Group 2

Experimental group

Description:

Ultrasound guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula

Treatment:

Device: Ultrasound guided percutaneous balloon dilatation

Group 3

Experimental group

Description:

Surgical reconstruction of the stenosis to reconstruction the lumen of arteriovenous fistula

Treatment:

Procedure: Surgical reconstruction