NCT02266238

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2014-10-16
• Last updated: 2014-10-16

Locations

1 site across 1 country: China