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

NCT00543348 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-03-21

No results posted yet for this study

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.

Conditions

  • Stenosis

Interventions

PROCEDURE

CUTTING BALLOON ANGIOPLASTY

CUTTING BALLOON

PROCEDURE

Balloon angioplasty

HIGH PRESSURE BALLOON

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • GEORGES HADDAD, MD, FACS · Henry Ford Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00543348 on ClinicalTrials.gov