Restenosis Following Paclitaxel Eluting Balloon Angioplasty of Hemodialysis Access Stenosis
Introduction: Narrowing of the draining vein occurs in >50% of hemodialysis fistula and left untreated will lead to loss of access. The narrowing is due to excessive growth of tissue in the vessel wall (intimal hyperplasia). The standard treatment is balloon dilatation. However, narrowing will inevitably recur in 2-3 months hence requiring further dilatation. Intimal hyperplasia also occurs in the heart and leg circulation. The drug paclitaxel has been used with great success in preventing intimal hyperplasia in these vessels following balloon dilatation. Administer locally, paclitaxel inhibits excess tissue growth in the vessel wall. The investigators believe that this drug will have similar effect in hemodialysis access..
Objective: To assess the effect of paclitaxel in hemodialysis access with narrowing. Paclitaxel is delivered by a paclitaxel-coated balloon. This balloon dilates the narrow segment and simultaneously delivers paclitaxel to the vessel wall.
Methodology: Patients with narrowed hemodialysis access are dilated with the paclitaxel-coated balloon or conventional balloon in randomized manner. The patency of the two groups are evaluated and compared at 6 months follow-up.
Potential benefit: Decrease number of balloon dilatations and hence hospital admissions, improve dialysis fistula function, and decrease overall economic cost.
|Renal Failure||Device: Percutaneous Transluminal Angioplasty (PTA) Device: Paclitaxel Eluting Balloon Angioplasty||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Local Delivery of Paclitaxel for Prevention of Restenosis in Hemodialysis Access|
- Primary patency [ Time Frame: at 6 months ]
- Transonic blood flows [ Time Frame: monthly for up to 6 months ]
|Study Start Date:||February 2012|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: Conventional Balloon Angioplasty||
Device: Percutaneous Transluminal Angioplasty (PTA)
Angioplasty with the use of Conventional balloon
|Experimental: Drug Eluting Balloon Angioplasty||
Device: Paclitaxel Eluting Balloon Angioplasty
Angioplasty with the use of paclitaxel eluting balloon
Other Name: Passeo-18 Lux (Biotronik)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001676
|University Health Network|
|Toronto, Ontario, Canada, M5G 2N2|
|Principal Investigator:||Kong Teng Tan, BCh MB||University Health Network, Toronto|