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

Arteriovenous Fistula Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02266238
• Other study ID #: CZHKI-HDVA-003
• Status: Not yet recruiting
• Phase: N/A
• First received: September 22, 2014
• Last updated: October 12, 2014
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: October 2014
• Source: Shanghai Changzheng Hospital
• Contact: Changlin Mei, MD
• Phone: 0086 21 81885411
• Email: chlmei1954[@]126.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Constriction, Pathologic
• Fistula
• Stenosis
• Uremia

Intervention

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.
• 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.

Procedure:
• Surgical reconstruction
Direct surgery to reconstruction the AVF lumen.

Locations

Country	Name	City	State
China	Shanghai Changzheng Hospital	Shanghai

Sponsors (7)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital	Beijing Haidian Hospital, First Affiliated Hospital of Zhejiang University, Sichuan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, The Second Affiliated Hospital of Dalian Medical University, Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the patency rate of the AVF after intervention	the patency rate including the primary and the secondary patency rate	24 month	No
Secondary	The success rate of AVF stenosis interventions	Described as %.	24 month	Yes
Secondary	The recurrence rate of AVF stenosis interventions	Described as %.	24 month	Yes
Secondary	The side effects of AVF stenosis interventions	Described as %.Side effects including bleeding, infection, thrombosis, artery steal syndrome, heart failure, inadequate dialysis, etc.	24 month	Yes
Secondary	The cost-effectiveness analysis of AVF stenosis interventions	Described as $.	24 month	No