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

August 10, 2016 updated by: Volcano Corporation

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

The purpose of this study is to demonstrate that IVUS identifies more instances of significant iliac and common femoral vein outflow obstruction than multiplanar venography.No hypothesis testing is planned.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy
        • Hesperia Hospital
  • Poland
      • Poznan, Poland
        • Szpital Kliniczny Przemienienia Pańskiego
  • United Kingdom
      • London, United Kingdom
        • St Thomas Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35924
        • University of Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Heart
    • Connecticut
      • Bridgeport, Connecticut, United States, 06614
        • Southern CT Vascular Center
      • Norwalk, Connecticut, United States, 06856
        • Norwalk Hospital
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Vein Center of Southwest Louisiana/Imperial Health
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10029
        • The Mount Sinai Medical Center
      • Stonybrook, New York, United States, 11794
        • SUNY Stony Brook University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Hospital
    • Pennsylvania
      • Bradford, Pennsylvania, United States, 16701
        • Allegheny Vein and Vascular Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with iliac compression disease CEAP classification 4-6. Hospitals, venous clinics

Description

Inclusion Criteria:

  • Subject must be > 18 and < 85 years of age
  • Willing to participate in and able to understand, read and sign the informed consent document before the planned procedure
  • CEAP clinical classification: C4, C5, or C6 (enrollment of C4 and C5 subjects will be capped at 50, such that at least 50 C6 subjects can be enrolled)
  • On duplex ultrasound: patent common femoral vein, and patent deep femoral vein, and/or femoral vein of the study leg
  • Undergoing iliofemoral and inferior vena caval venography with the intent to treat obstructive lesions

Exclusion Criteria:

  • Subject cannot or will not provide written informed consent
  • Previous venous stent implantation involving the study leg or inferior vena cava
  • Previous venovenous bypass surgery involving the study leg
  • Known metal allergy precluding endovascular stent implantation
  • Known reaction or sensitivity to iodinated contrast that cannot be managed with premedication
  • Subjects who are pregnant (women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment
  • Severe, untreated (and readily treatable) superficial venous reflux (great saphenous vein >7 mm in diameter, and/or small saphenous vein >4 mm in diameter)
  • Acute deep venous thrombosis involving either leg
  • Known history of chronic total occlusion of the common femoral vein of the study leg.
  • Known history of thrombophilia (e.g., protein C or S deficiency, anti-thrombin III deficiency, presence of lupus anticoagulant, etc.)
  • Venous compression caused by tumor encasement
  • Venous outflow obstruction caused by tumor thrombus
  • Life expectancy of less than 6 months
  • Elevated baseline blood creatinine (value greater than the upper limit of the normal range)
  • Any concurrent disease or condition that, in the opinion of the Investigator, would make the subject unsuitable for participation in the study; examples include but are not limited to the inability to lie supine for the index procedure (e.g., severe congestive heart failure), thrombocytopenia or other hematological disorders associated with an unacceptable risk of bleeding, implanted orthopedic hardware that precludes proper imaging, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Venography and IVUS imaging guiding treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
100 patients with Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) classification C4-6 undergoing iliac and common femoral and venography with intention to treat venous outflow obstruction.
Time Frame: 6 month
Primary Endpoints: Both venous IVUS and traditional venography will provide measurements of minimum and maximum diameter reduction due to iliofemoral venous obstruction/compression; cross-sectional area reduction will also be measured by IVUS, and calculated for venography (from min. and max. diameters, assuming elliptical cross-section6). The diameters and cross-sectional area are compared to adjacent reference vessel in order to calculate the degree of stenosis. The percentage of significant stenosis detected at various thresholds [e.g., 50%, 60%, 70%, 80%, for diameter reduction, and (separately) for area reduction] with each method will be compared in a pair-wise fashion. This will be done with descriptive statistics of the detection rates for each method, and the rate of discordance between the two. In addition to the binary outcome of significant stenosis, the numeric values for diameters and cross-sectional areas will be compared.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Volcano Corporation

Investigators

  • Principal Investigator: Paul Gagne, M.D., Southern Connecticut Vascular Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

May 14, 2014

First Submitted That Met QC Criteria

May 15, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 007-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Iliac Venous Compression

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe