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

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

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.

Study Overview

• Status: Unknown
• Conditions: Arteriovenous Fistula; Uremia; Stenosis
• Intervention / Treatment: Device: DSA guided percutaneous balloon dilatation; Device: Ultrasound guided percutaneous balloon dilatation; Procedure: Surgical reconstruction

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 Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200003
    • Shanghai Changzheng Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; DSA guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula	Device: DSA 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.
Experimental: Group 2; Ultrasound guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula	Device: Ultrasound 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.
Experimental: Group 3; Surgical reconstruction of the stenosis to reconstruction the lumen of arteriovenous fistula	Procedure: Surgical reconstruction; Direct surgery to reconstruction the AVF lumen.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital
• Collaborators: First Affiliated Hospital of Zhejiang University; The First Affiliated Hospital of Zhengzhou University; Zhongda Hospital; Sichuan Provincial People's Hospital; Beijing Haidian Hospital; The Second Affiliated Hospital of Dalian Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: September 22, 2014
• First Submitted That Met QC Criteria: October 12, 2014
• First Posted (Estimate): October 16, 2014

Study Record Updates

• Last Update Posted (Estimate): October 16, 2014
• Last Update Submitted That Met QC Criteria: October 12, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Constriction, Pathologic; Arteriovenous Fistula
• Other Study ID Numbers: CZHKI-HDVA-003