Clinical trial NCT02266238: Stenosis of Arteria-Venous Fistula in Maintenance Hemodialysis Patients: Early Intervention Trial
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
Overall status: UNKNOWN
Phase: NA
Conditions: Uremia
Arteriovenous Fistula
Stenosis
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Zhejiang University
name: Zhongda Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Sichuan Provincial People's Hospital
name: The Second Affiliated Hospital of Dalian Medical University
name: Beijing Haidian Hospital
First posted: 2014-10-16
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the patency rate of the AVF after intervention
timeFrame: 24 month
Secondary outcomes:
measure: The success rate of AVF stenosis interventions
timeFrame: 24 month
measure: The recurrence rate of AVF stenosis interventions
timeFrame: 24 month
measure: The side effects of AVF stenosis interventions
timeFrame: 24 month
measure: The cost-effectiveness analysis of AVF stenosis interventions
timeFrame: 24 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Changlin Mei, MD
role: PRINCIPAL_INVESTIGATOR
References: