PAVE STUDY - KCL
Paclitaxel assisted balloon Angioplasty of Venous stenosis in haEmodialysis access (PAVE); A double-blind randomised controlled clinical trial to determine the efficacy of paclitaxel-assisted balloon angioplasty of venous stenoses in haemodialysis access
Purpose of clinical trial :
Randomised Controlled Trial to assess the efficacy of additional paclitaxel-coated balloon fistuloplasty compared to plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis.
Number of patients : 211
The primary endpoint is time to end of target lesion primary patency (TLPP).
Angiographically determined late lumen loss
The rate of binary angiographic re-stenosis
Core Laboratory activity : Core laboratory Plan , guidelines for centers (Instructions to the sites, Technical worksheet), Database corelab development,
Corelab analysis : QCA and qualitative analysis (Pre , post , 6 months follow-up, event )
Corelab report and statistical