Sirolimus Use in Angioplasty for Vascular Access Extension

This is a randomized control study to determine the feasibility of using sirolimus peri-angioplasty to compare the time from primary failure or angioplasty intervention to second or next angioplasty intervention or graft failure to a control group who would not have received Sirolimus

Inclusion

• hemodialysis patients referred for angioplasty for hemodialysis access stenosis through either access flow or clinical monitoring in either an AVF or AVG
• > 18 years of age.
• Total white blood cell count > 3 x 109 /L and platelet count > 100.0 x 103/uL
• Fasting triglycerides < 4.0 mmol/L, fasting cholesterol < 7.8 mmol/L while on optimal lipid lowering therapy.

Exclusion criteria

• A woman who is pregnant or breastfeeding
• Active malignancy
• Concomitant treatment with immunosuppressant medications
• Active infection or treated for infection within the last 30 days
• Pre-existing interstitial lung disease
• Thrombocytopenia with platelets less than 100 109/L
• Previous renal or other solid organ transplant
• Preexisting liver failure
• Life expectancy less than 6 months
• Planned major surgery or major surgery within the last 6 months
• History of malignancy within the previous 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).
• Known history of any coronary intervention within the 6 months prior to current screening
• Prior or current use of Sirolimus or any of its derivatives within 3 months prior to angioplasty
• Active gastrointestinal disorder that may interfere with drug absorption
• Known to be HIV positive or known active hepatitis B or C infection
• Treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or ketoconazole (known to interact with Sirolimus) that is not discontinued before starting Sirolimus treatment.