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

Henry Ford Health System · 2007
ClinicalTrials.gov · Datasets · License: Public Domain · 2007
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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.
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