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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02266238

Acronym

SAVEIT

Enrollment

450

Registered

2014-10-16

Start date

2015-01-31

Completion date

2017-12-31

Last updated

2014-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uremia, Arteriovenous Fistula, Stenosis

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.

Interventions

DEVICEDSA guided percutaneous balloon dilatation

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.

DEVICEUltrasound guided percutaneous balloon dilatation

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.

PROCEDURESurgical reconstruction

Direct surgery to reconstruction the AVF lumen.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
the patency rate of the AVF after intervention	24 month	the patency rate including the primary and the secondary patency rate

Secondary

Measure	Time frame	Description
The success rate of AVF stenosis interventions	24 month	Described as %.
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 $.

Countries

China

Contacts

Primary ContactChanglin Mei, MD

chlmei1954@126.com0086 21 81885411

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026