Restenosis Following Paclitaxel Eluting Balloon Angioplasty of Hemodialysis Access Stenosis

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Local Delivery of Paclitaxel for Prevention of Restenosis in Hemodialysis Access

Conditions
-----------------
Renal Failure

Intervention / Treatment
-----------------
* Device: Percutaneous Transluminal Angioplasty (PTA)
* Device: Paclitaxel Eluting Balloon Angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemodialysis access located in the forearm or upper arm Patient with clinical or hemodynamic evidence of graft dysfunction Hemodialysis access is > 3 months old Exclusion Criteria: Intervention of the vascular access circuit within the past 30 days Thrombosed/clotted access Evidence of systemic infection or a local infection associated with the graft Positive pregnancy test within 7 days before enrolment Patient is scheduled for a kidney transplant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Balloon Angioplasty<br> | Device: Percutaneous Transluminal Angioplasty (PTA)<br>* Angioplasty with the use of Conventional balloon<br>|
| Experimental: Drug Eluting Balloon Angioplasty<br> | Device: Paclitaxel Eluting Balloon Angioplasty<br>* Angioplasty with the use of paclitaxel eluting balloon<br>* Other names: Passeo-18 Lux (Biotronik);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transonic blood flows |  | monthly for up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal failure, Restenosis, Dialysis access, Paclitaxel, Angioplasty, Intimal hyperplasia