RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses

A Randomised-Controlled Study Comparing the Peripheral Cutting BalloonTM (Boston Scientific Co.) With a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses

The proposed study will investigate the efficacy of the peripheral cutting balloon (PBC) compared to the high pressure balloon in dilating venous stenosis in hemodialysis fistulas.

2. SPECIFIC AIMS

Study endpoints will be:

Primary Endpoint

1. Primary and assisted patency at 6 months

Secondary Endpoints:

1. Procedure effectiveness/residual stenosis
2. Procedure-related complications
3. Primary patency and primary assisted patency 12 months
4. Secondary patency at 6 and 12 months
5. Number/type of secondary interventions.

Inclusion Criteria:

• Dysfunctional fistulas will be recruited based on the presence of clinical and hemodialysis parameters

Exclusion Criteria:

• Arteriovenous prosthetic grafts