Randomized controlled trial for endovascular intervention for dysfunctional dialysis access with drug-coated balloon versus plain balloon angioplasty

Phase 4

Completed

• Conditions: Dysfunctional haemodialysis access; Renal failure on haemodialysis; Surgery - Surgical techniques; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12616000789460
• Lead Sponsor: Department of Surgery, Pamela Youde Nethersole Eastern Hospital, Hong Kong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-16
• Study Completion: 2019-04-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Native arteriovenous fistula or prosthetic arteriovenous graft in the upper limb
Vascular access actively used for hemodialysis
At least 1 previous successful session of hemodialysis via access
Clinical signs of failing access due to presence of significant anatomic stenosis
Detection of elevated venous pressure during dialysis and/or decreased blood flow
Angiographically/sonographically proven venous outflow stenosis >50%

Exclusion Criteria

Patient unable to provide informed consent
Patient unable to abide with study follow-up protocol
Patient participating in other relevant or conflicting studies
Vascular access circuit placed in the lower extremities
Bare metal stent or stent graft placed previously
Hemodynamically significant stenosis of the central venous system
Metastatic malignancy or other terminal medical condition
Limited life expectancy (<6 months)
Blood coagulation disorders
Sepsis or active infection
Recent arm thrombophlebitis (<6 months)
Allergy or other known contraindication to iodinated contrast media, heparin, or paclitaxel
Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target lesion primary patency rate at 12 months (functional dialysis access with <50% angiographic re-stenosis and without any repeat interventional procedures)[12 months post intervention]

Secondary Outcome Measures

Name	Time	Method
Device Success: Post-procedure angiogram with residual stenosis <30% without high pressure post-dilation[Post procedure angiogram is performed intraoperatively, immediately after angioplasty intervention];Technical success: Post-procedure angiogram final residual stenosis <30%[Post procedure angiogram is performed intraoperatively, after angioplasty +/- high-pressure balloon if device failure +/- stent in case of flow-limiting dissection or rupture.];Clinical success (smooth haemodialysis for 3 consecutive sessions) <br>[1-2 week post intervention]