Cook Enforcer Post-Market Study

Randomized Clinical Study to Evaluate the Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter in Treatment of Arteriovenous Dialysis Access Circuit Stenosis

The purpose of this study is to evaluate the performance of the Cook Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter (or Enforcer balloon) in treating narrowed blood vessels compared to treatment with a conventional angioplasty balloon.

Inclusion Criteria:

• Clinical or physiological abnormalities which indicate dialysis access dysfunction (e.g., decreased access blood flow, elevated venous pressure, decreased dialysis dose, abnormal physical exam)

Exclusion Criteria:

• Less than 18 years old
• Pregnant, lactating, or planning to become pregnant in the 3 months following enrollment
• Underwent any surgical or interventional procedure of the access circuit less than or equal to 30 days prior to enrollment
• Scheduled for a kidney transplant
• Stent or stent graft in the arteriovenous (AV) dialysis access circuit