Status:

COMPLETED

Fluency Stent-Graft Versus Luminex Stent for Angioplasty of Recurrent Stenosis of the Cephalic Arch in Autogenous Arteriovenous (AV) Access for Hemodialysis

Lead Sponsor:

Shaare Zedek Medical Center

Conditions:

Stenosis

Eligibility:

All Genders

15+ years

Phase:

PHASE4

Brief Summary

The type of hemodialysis access and preservation of this access greatly influences the quality of life and survival of patients undergoing hemodialysis. The Kidney Disease Outcomes Quality Initiative ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Patients included in this study would be presented for intervention after observation in the Vascular Access Unit for one of the following:
  • the recurrent cephalic arch stenosis identified on periodic duplex scanning, performed by one of the surgeons from the Vascular Access Unit;
  • reduction of flow rate of more than 20% from baseline access flow rate;
  • dynamic venous pressures exceeded threshold levels three consecutive times; or
  • clinical signs (arm swelling, pulsatile fistula, prolonged bleeding from puncture sites) suggesting fistula dysfunction in a patient with previously treated cephalic arch stenosis.

Exclusion

    Key Trial Info

    Start Date :

    May 1 2006

    Trial Type :

    INTERVENTIONAL

    End Date :

    August 1 2006

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT00318435

    Start Date

    May 1 2006

    End Date

    August 1 2006

    Last Update

    August 19 2008

    Active Locations (1)

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    Shaare Zedek Medical Center

    Jerusalem, Israel