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

Sponsor

Shanghai Changzheng Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02266238

Collaborator

First Affiliated Hospital of Zhejiang University (Other), Zhongda Hospital (Other), The First Affiliated Hospital of Zhengzhou University (Other), Sichuan Provincial People's Hospital (Other), The Second Affiliated Hospital of Dalian Medical University (Other), Beijing Haidian Hospital (Other)

450

Enrollment

Location

Arms

Duration (Months)

12.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uremia Arteriovenous Fistula Stenosis	Device: DSA guided percutaneous balloon dilatation Device: Ultrasound guided percutaneous balloon dilatation Procedure: Surgical reconstruction	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

the patency rate of the AVF after intervention [24 month]
the patency rate including the primary and the secondary patency rate

Secondary Outcome Measures

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 $.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Changzheng Hospital	Shanghai		China	200003

Sponsors and Collaborators

Shanghai Changzheng Hospital
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

Investigators

Principal Investigator: Changlin Mei, MD, Shanghai Changzheng Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Changlin Mei, Professor, Director, Division of Nephrology, Shanghai Changzheng Hospital

ClinicalTrials.gov Identifier:

NCT02266238

Other Study ID Numbers:

CZHKI-HDVA-003

First Posted:

Oct 16, 2014

Last Update Posted:

Oct 16, 2014

Last Verified:

Oct 1, 2014

Additional relevant MeSH terms:

Arteriovenous Fistula

Constriction, Pathologic

Fistula

Study Results

No Results Posted as of Oct 16, 2014