- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02266238
Stenosis of Arteria-Venous Fistula in Maintenance Hemodialysis Patients: Early Intervention Trial (SAVEIT)
October 12, 2014 updated by: Changlin Mei, Shanghai Changzheng Hospital
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
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 Type
Interventional
Enrollment (Anticipated)
450
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Changlin Mei, MD
- Phone Number: 0086 21 81885411
- Email: chlmei1954@126.com
Study Locations
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Shanghai, China, 200003
- Shanghai Changzheng Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
DSA guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula
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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.
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Experimental: Group 2
Ultrasound guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula
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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.
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Experimental: Group 3
Surgical reconstruction of the stenosis to reconstruction the lumen of arteriovenous fistula
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Direct surgery to reconstruction the AVF lumen.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the patency rate of the AVF after intervention
Time Frame: 24 month
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the patency rate including the primary and the secondary patency rate
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24 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The success rate of AVF stenosis interventions
Time Frame: 24 month
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Described as %.
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24 month
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The recurrence rate of AVF stenosis interventions
Time Frame: 24 month
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Described as %.
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24 month
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The side effects of AVF stenosis interventions
Time Frame: 24 month
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Described as %.Side effects including bleeding, infection, thrombosis, artery steal syndrome, heart failure, inadequate dialysis, etc.
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24 month
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The cost-effectiveness analysis of AVF stenosis interventions
Time Frame: 24 month
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Described as $.
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24 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- CZHKI-HDVA-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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