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

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ClinicalTrials.gov Identifier: NCT02142062
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Volcano Corporation

Brief Summary:
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.

Condition or disease
Iliac Venous Compression

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : July 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : August 2016

Group/Cohort
Venography and IVUS imaging guiding treatment



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with iliac compression disease CEAP classification 4-6. Hospitals, venous clinics
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142062


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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Volcano Corporation
ClinicalTrials.gov Identifier: NCT02142062     History of Changes
Other Study ID Numbers: 007-13
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Keywords provided by Volcano Corporation:
Venous outflow obstruction
Iliac Vein
Common Femoral Vein
Iliac Compression