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

Stenosis Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00543348
Study type Interventional
Source Henry Ford Health System
Contact
Status Withdrawn
Phase N/A
Start date September 2007
Completion date March 2008
View Details
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