Venogram vs. IVUS for Diagnosing Iliac Vein Obstruction (VIDIO)

  • Research type

    Research Study

  • Full title

    Prospective, single-arm, multi-center, pilot study of IVUS imaging used as an adjunct to multiplanar venography during iliac-common femoral vein assessment for possible endovascular intervention.

  • IRAS ID

    158705

  • Contact name

    Stephen Black

  • Contact email

    stephen.black@gstt.nhs.uk

  • Sponsor organisation

    Volcano BVBA

  • Clinicaltrials.gov Identifier

    NCT02142062

  • Duration of Study in the UK

    1 years, 6 months, 29 days

  • Research summary

    The purpose of this study is to evaluate the performance of IVUS when used with venography to determine treatment of your vessels. IVUS is a type of ultrasound that is used to view the vessels from the inside and venography is a procedure in which an X-ray of the veins is taken after a special dye is injected into the veins. The IVUS images will allow the doctor to perform some additional calculations. The results of this study could allow future patients to undergo the same procedure by using these additional measurements to better evaluate possible narrowing in a patient’s vessels. The IVUS catheter used during the patient's leg procedure is one that is typically used for gaining information for their doctor to determine the best course of care for them.

    The IVUS catheter is passed into the vein that carries blood from patient's legs, and will then take pictures of the inside of the vein using sound waves to produce an image. These images may give their physician important information related to the size of, and narrowing of their veins. This information is transferred and saved to a computer. The information obtained from this study will be saved and researchers experienced in this field will study the results.

    The study is being done at up to 20 sites in the United States and Europe. There will be up to 100 patients enrolled in this study.

    Patients participation in the study will last for the duration of the leg procedure, with additional follow-up visits at intervals of 1 month and again at 6 months after procedure is completed.

    The IVUS catheter used in this study has approval in the United States and the European Union.

  • REC name

    East of England - Cambridge Central Research Ethics Committee

  • REC reference

    14/EE/1242

  • Date of REC Opinion

    19 Nov 2014

  • REC opinion

    Unfavourable Opinion