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

Primary Purpose

Uremia, Arteriovenous Fistula, Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DSA guided percutaneous balloon dilatation
Ultrasound guided percutaneous balloon dilatation
Surgical reconstruction
Sponsored by
Shanghai Changzheng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uremia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shanghai Changzheng Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

the patency rate of the AVF after intervention
the patency rate including the primary and the secondary patency rate

Secondary Outcome Measures

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

Full Information

First Posted
September 22, 2014
Last Updated
October 12, 2014
Sponsor
Shanghai Changzheng Hospital
Collaborators
First Affiliated Hospital of Zhejiang University, Zhongda Hospital, The First Affiliated Hospital of Zhengzhou University, Sichuan Provincial People's Hospital, The Second Affiliated Hospital of Dalian Medical University, Beijing Haidian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02266238
Brief Title
Stenosis of Arteria-Venous Fistula in Maintenance Hemodialysis Patients: Early Intervention Trial
Acronym
SAVEIT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Changzheng Hospital
Collaborators
First Affiliated Hospital of Zhejiang University, Zhongda Hospital, The First Affiliated Hospital of Zhengzhou University, Sichuan Provincial People's Hospital, The Second Affiliated Hospital of Dalian Medical University, Beijing Haidian Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremia, Arteriovenous Fistula, Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
DSA guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Ultrasound guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Surgical reconstruction of the stenosis to reconstruction the lumen of arteriovenous fistula
Intervention Type
Device
Intervention Name(s)
DSA guided percutaneous balloon dilatation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Ultrasound guided percutaneous balloon dilatation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgical reconstruction
Intervention Description
Direct surgery to reconstruction the AVF lumen.
Primary Outcome Measure Information:
Title
the patency rate of the AVF after intervention
Description
the patency rate including the primary and the secondary patency rate
Time Frame
24 month
Secondary Outcome Measure Information:
Title
The success rate of AVF stenosis interventions
Description
Described as %.
Time Frame
24 month
Title
The recurrence rate of AVF stenosis interventions
Description
Described as %.
Time Frame
24 month
Title
The side effects of AVF stenosis interventions
Description
Described as %.Side effects including bleeding, infection, thrombosis, artery steal syndrome, heart failure, inadequate dialysis, etc.
Time Frame
24 month
Title
The cost-effectiveness analysis of AVF stenosis interventions
Description
Described as $.
Time Frame
24 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changlin Mei, MD
Phone
0086 21 81885411
Email
chlmei1954@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changlin Mei, MD
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
ZIP/Postal Code
200003
Country
China

12. IPD Sharing Statement

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

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