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

NCT ID: NCT02266238

Last Updated: 2014-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-12-31

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.

Conditions

Uremia; Arteriovenous Fistula; Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

DSA guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula

Group Type: EXPERIMENTAL

DSA guided percutaneous balloon dilatation

Intervention Type: DEVICE

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.

Group 2

Ultrasound guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula

Group Type: EXPERIMENTAL

Ultrasound guided percutaneous balloon dilatation

Intervention Type: DEVICE

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.

Group 3

Surgical reconstruction of the stenosis to reconstruction the lumen of arteriovenous fistula

Group Type: EXPERIMENTAL

Surgical reconstruction

Intervention Type: PROCEDURE

Direct surgery to reconstruction the AVF lumen.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Surgical reconstruction

Direct surgery to reconstruction the AVF lumen.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: collaborator

Zhongda Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

Sichuan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: collaborator

Beijing Haidian Hospital

OTHER

Sponsor Role: collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Changlin Mei

Professor, Director, Division of Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Changlin Mei, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Changzheng Hospital

Locations

Shanghai Changzheng Hospital

Shanghai, , China

Countries

China

Central Contacts

Changlin Mei, MD

Role: CONTACT

chlmei1954@126.com

0086 21 81885411

Other Identifiers

CZHKI-HDVA-003

Identifier Type: -

Identifier Source: org_study_id