Vascular Diseases, Kidney Diseases
Conditions
Keywords
Haemodialysis, Fistula, Stenosis, Paclitaxel, Drug-eluting balloon, Angioplasty
Brief summary
Background Conventional percutaneous transluminal angioplasty is still considered standard treatment for treatment of dysfunctional haemodialysis fistulas and grafts. The most important drawback with this treatment is frequent restenosis leading to a high number of secondary procedures. There is conflicting evidence in the literature regarding primary or secondary treatment with drug eluting balloons (DEB). These balloons deliver Paclitaxel locally, which acts as an antiproliferative drug and may improve treatment outcomes. Methods This study was conducted as a prospective 1:1 randomized single centre clinical trial. Participants had primary or re-stenotic lesions in native upper extremity arteriovenous fistulas or at the graft-venous anastomosis. Patients were randomized to direct primary dilatation, with either a standard balloon or a DEB. The primary effectiveness endpoints were freedom from target lesion revascularization (TLR), access circuit revascularization or thrombosis, functional status of access circuit at 12 months. Secondary endpoints were procedural complications, procedural success, follow up survival and time to target lesion revascularization.
Interventions
DEVICEAdvance PTX
PTA in Dysfunctional Haemodialysis Access
DEVICEAdvance LP (Low Profile)
Plain Old Balloon Angioplasty (POBA)
DRUGPaclitaxel (PTX)
Paclitaxel (PTX)
Sponsors
Skane University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Active dialysis with a mature upper extremity dysfunctional haemodialysis access * Primary stenosis or nonstented restenosis in a native AV fistula or at graft-venous location * Adult (\>18 years) * Target vessel diameter 3-8mm
Exclusion criteria
* Thrombosed access * In stent restenosis * Pregnancy * Age less than 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from restenosis in treated vascular access | 12 months | Freedom from Restenosis and Target Lesion Revascularization (TLR) during 12 months follow up |
| Stenosis or occlusion in treated vascular access | 12 months | Treated Denovo Stenosis or Occlusion during 12 months follow up, i.e a new stenosis \>50%, not treated before in the study, and at another location in the vascular access circuit (upper arm haemodialysis access) |
| Number of Participants with a vascular access in full clinical use for haemodialysis at 12 months | 12 months | Functional status of vascular access. |
Outcome results
None listed