Comparison of drug-eluting and plain balloon angioplasty in the treatment of stenosis of vascular access for dialysis

Not Applicable

Completed

• Conditions: Treatment with stenosis in the vascular access for dialysis in adult patients using percutaneous transluminal angioplasty; Surgery

• Registration Number: ISRCTN11414306
• Lead Sponsor: Charles University

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36556023/ (added 28/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-11-30
• Study Start: 2022-12-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. Aged >18 years old
2. Life expectancy >1 year
3. Clinically mature dialysis fistula (AVG or AVF) already used for hemodialysis with adequate pump speed and dialysis efficacy for at least 4 consecutive sessions with the two-needle technique
4. Signs of fistula dysfunction (absent thrill, low flow, high venous pressure, high pulsatility, needling problems, abnormal pulsatility, abnormal auscultation, extremity edema, etc)
5. Hemodynamically significant (>50%) stenosis in juxta-anastomotic or outflow vein of AVF (excluding central veins defined as veins medial to the lateral margin of the first rib) or in the venous anastomosis, juxta-anastomotic segment or outflow vein in AVG (excluding central veins).

Exclusion Criteria

1. Access circuit thrombosis in the last year
2. History of graft infection
3. Prior use of a drug-eluting balloon catheter in the access circuit
4. In-stent restenosis in bare metal or covered stent
5. Angiography contraindications (e.g. severe contrast media allergy)
6. Two or more distinct significant stenoses in the access circuit

Study & Design

• Study Type: Interventional
• Study Design: Not specified