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

Conditions

• Uremia
• Arteriovenous Fistula
• Stenosis

Interventions

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.

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.

PROCEDURE

Surgical reconstruction

Direct surgery to reconstruction the AVF lumen.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• Zhongda Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Beijing Haidian Hospital

  collaborator OTHER

• Shanghai Changzheng Hospital

  lead OTHER

Principal Investigators

• Changlin Mei, MD · Shanghai Changzheng Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• China

Study Locations