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Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts

NCT01929369 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2015-02-20

No results posted yet for this study

Summary

This pilot study will provide data to aid in the planning of a follow-up multi-center randomized, controlled trial (RCT). As such, the sample size for this pilot is not driven by formal statistical hypothesis testing. Rather, the sample size of 100 patients (50 per arm) was derived in consultation with the study PI and Co-PI who are experts in vascular surgery, and in particular, the field of hemodialysis access interventions. The results of this pilot study will provide the data that is necessary for generation of specific hypotheses that can then be formally tested in the follow-up RCT

Conditions

  • THROMBOSED AV GRAFTS

Sponsors & Collaborators

  • Volcano Corporation

    lead INDUSTRY

Principal Investigators

  • John Ross, MD · Regional Medical Center

Eligibility

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

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-09-30
Completion
2014-12-31

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 NCT01929369 on ClinicalTrials.gov