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
1 other identifier
interventional
450
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2014
CompletedFirst Posted
Study publicly available on registry
October 16, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedOctober 16, 2014
October 1, 2014
2.9 years
September 22, 2014
October 12, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
the patency rate of the AVF after intervention
the patency rate including the primary and the secondary patency rate
24 month
Secondary Outcomes (4)
The success rate of AVF stenosis interventions
24 month
The recurrence rate of AVF stenosis interventions
24 month
The side effects of AVF stenosis interventions
24 month
The cost-effectiveness analysis of AVF stenosis interventions
24 month
Study Arms (3)
Group 1
EXPERIMENTALDSA guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula
Group 2
EXPERIMENTALUltrasound guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula
Group 3
EXPERIMENTALSurgical reconstruction of the stenosis to reconstruction the lumen of arteriovenous fistula
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Changzheng Hospitallead
- First Affiliated Hospital of Zhejiang Universitycollaborator
- Zhongda Hospitalcollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- Sichuan Provincial People's Hospitalcollaborator
- The Second Affiliated Hospital of Dalian Medical Universitycollaborator
- Beijing Haidian Hospitalcollaborator
Study Sites (1)
Shanghai Changzheng Hospital
Shanghai, 200003, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Changlin Mei, MD
Shanghai Changzheng Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Director, Division of Nephrology
Study Record Dates
First Submitted
September 22, 2014
First Posted
October 16, 2014
Study Start
January 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
October 16, 2014
Record last verified: 2014-10