PAVE STUDY - KCL

Brief summary

Title :

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

Primary endpoints

The primary endpoint is time to end of target lesion primary patency (TLPP).

Secondary endpoints:

Angiographically determined late lumen loss

The rate of binary angiographic re-stenosis

CERC Services

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

Center number : 19