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Stenting of Haemodialysis Acces Trial

NCT00642083 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-12-15

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the efficacy of a PTFE covered stent-graft in the prevention of outflow re-stenosis in loop fistula in a prospective trial.

Conditions

  • Outflow Stenosis

Interventions

DEVICE

Viabahn stent-graft

The viabahn stent-graft is a combined ePTFE-Nitinol self-expanding stent-graft preloaded on a catheter-based delivery system. It was originally designed for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4.8 to 7.5 mm. This device is also increasingly used for the exclusion of popliteal aneurysms. Its flexibility might make the device ideal for the treatment of recurrent outflow stenosis in AV loop-fistula.

Sponsors & Collaborators

  • W.L.Gore & Associates

    collaborator INDUSTRY

  • Rijnstate Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Netherlands

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 NCT00642083 on ClinicalTrials.gov