Randomized controlled trial for endovascular intervention for dysfunctional dialysis access with drug-coated balloon versus plain balloon angioplasty
Paclitaxel-eluting balloon Versus plain angioplasty balloon for dysfunctional dialysis access: a prospective double-blinded randomized controlled trial
Department of Surgery, Pamela Youde Nethersole Eastern Hospital, Hong Kong
40 participants
Jun 7, 2016
Interventional
Conditions
Summary
Dysfunction haemodialysis access is one of the common problems encountered in renal patients. Endovenous intervention with plain balloon angioplasty is one of the common and effective methods to maintain the arteriovenous flow with high success rate. However, the patency rate is low from six months onwards. Repeated interventions on these patients create morbidity and also increases the financial burden on the hospital. Drug eluting balloon may help to reduce the re-stenosis rate and hence lower the morbidity to patients and reduce the cost. The purpose of this study is to compare the target lesion primary patency rate at 12 months between paclitaxel-eluting balloon (PEB) vs plain balloon angioplasty (BA) for the treatment of venous stenoses of the dysfunctional vascular access patients undergoing haemodialysis
Eligibility
Inclusion Criteria6
- 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 Criteria13
- 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
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Interventions
Randomised trial where participants with dysfunctional haemodialysis access are assessed by pre-treatment duplex ultrasound. Patients will assessed, counselled and consented by the same vascular team. They will then be allocated to receiving percutaneous transluminal angioplasty with either paclitaxel coated balloon or plain ( control) balloon. A single one-off intervention will be performed the same vascular surgeon in the vascular operating theatre in the same hospital. Surgical techniques will be standardised, performed under local anaesthetic, diagnostic angiogram performed and the appropriate sized balloon inflated to 1 minute to nominal pressure. For device failure, further angioplasty is performed with introduction of a high-pressure balloon of appropriate size and inflation to appropriate pressure for three minutes. In case of a flow-limiting dissection, a bare metal nitinol stent of appropriate size is introduced and placed; and in case of a rupture, a covered stent of appropriate size is introduced and placed. A post-procedure angiogram is performed.
Locations(1)
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ACTRN12616000789460