Venogram vs. Intravascular Ultrasound (IVUS) for Diagnosing Iliac Vein Obstruction
NCT ID: NCT02142062
Last Updated: 2016-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2014-07-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Venography and IVUS imaging guiding treatment
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Volcano Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Gagne, M.D.
Role: PRINCIPAL_INVESTIGATOR
Southern Connecticut Vascular Center
Locations
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University of Alabama
Birmingham, Alabama, United States
Arizona Heart
Phoenix, Arizona, United States
Southern CT Vascular Center
Bridgeport, Connecticut, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Vein Center of Southwest Louisiana/Imperial Health
Lake Charles, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
The Mount Sinai Medical Center
New York, New York, United States
SUNY Stony Brook University Medical Center
Stony Brook, New York, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, United States
Allegheny Vein and Vascular Clinic
Bradford, Pennsylvania, United States
Hesperia Hospital
Modena, , Italy
Szpital Kliniczny Przemienienia Pańskiego
Poznan, Poznan, Poland
St Thomas Hospital
London, , United Kingdom
Countries
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References
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Murad MH, Coto-Yglesias F, Zumaeta-Garcia M, Elamin MB, Duggirala MK, Erwin PJ, Montori VM, Gloviczki P. A systematic review and meta-analysis of the treatments of varicose veins. J Vasc Surg. 2011 May;53(5 Suppl):49S-65S. doi: 10.1016/j.jvs.2011.02.031.
Bergan JJ, Schmid-Schonbein GW, Coleridge Smith PD, Nicolaides AN, Boisseau MR, Eklof B. Chronic venous disease. Minerva Cardioangiol. 2007 Aug;55(4):459-76. No abstract available. English, Italian.
Raju S, Neglen P. Clinical practice. Chronic venous insufficiency and varicose veins. N Engl J Med. 2009 May 28;360(22):2319-27. doi: 10.1056/NEJMcp0802444. No abstract available.
Neglen P, Raju S. Intravascular ultrasound scan evaluation of the obstructed vein. J Vasc Surg. 2002 Apr;35(4):694-700. doi: 10.1067/mva.2002.121127.
Raju S, Neglen P. High prevalence of nonthrombotic iliac vein lesions in chronic venous disease: a permissive role in pathogenicity. J Vasc Surg. 2006 Jul;44(1):136-43; discussion 144. doi: 10.1016/j.jvs.2006.02.065.
Murphy EH, Broker HS, Johnson EJ, Modrall JG, Valentine RJ, Arko FR 3rd. Device and imaging-specific volumetric analysis of clot lysis after percutaneous mechanical thrombectomy for iliofemoral DVT. J Endovasc Ther. 2010 Jun;17(3):423-33. doi: 10.1583/10-3088.1.
Raju S. Best management options for chronic iliac vein stenosis and occlusion. J Vasc Surg. 2013 Apr;57(4):1163-9. doi: 10.1016/j.jvs.2012.11.084. Epub 2013 Feb 20.
Alhalbouni S, Hingorani A, Shiferson A, Gopal K, Jung D, Novak D, Marks N, Ascher E. Iliac-femoral venous stenting for lower extremity venous stasis symptoms. Ann Vasc Surg. 2012 Feb;26(2):185-9. doi: 10.1016/j.avsg.2011.05.033. Epub 2011 Oct 22.
Vasquez MA, Rabe E, McLafferty RB, Shortell CK, Marston WA, Gillespie D, Meissner MH, Rutherford RB; American Venous Forum Ad Hoc Outcomes Working Group. Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American Venous Forum Ad Hoc Outcomes Working Group. J Vasc Surg. 2010 Nov;52(5):1387-96. doi: 10.1016/j.jvs.2010.06.161. Epub 2010 Sep 27.
Stacey MC, Burnand KG, Layer GT, Pattison M, Browse NL. Measurement of the healing of venous ulcers. Aust N Z J Surg. 1991 Nov;61(11):844-8. doi: 10.1111/j.1445-2197.1991.tb00169.x.
Eklof B, Rutherford RB, Bergan JJ, Carpentier PH, Gloviczki P, Kistner RL, Meissner MH, Moneta GL, Myers K, Padberg FT, Perrin M, Ruckley CV, Smith PC, Wakefield TW; American Venous Forum International Ad Hoc Committee for Revision of the CEAP Classification. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg. 2004 Dec;40(6):1248-52. doi: 10.1016/j.jvs.2004.09.027.
Gagne PJ, Gasparis A, Black S, Thorpe P, Passman M, Vedantham S, Marston W, Iafrati M. Analysis of threshold stenosis by multiplanar venogram and intravascular ultrasound examination for predicting clinical improvement after iliofemoral vein stenting in the VIDIO trial. J Vasc Surg Venous Lymphat Disord. 2018 Jan;6(1):48-56.e1. doi: 10.1016/j.jvsv.2017.07.009. Epub 2017 Oct 13.
Gagne PJ, Tahara RW, Fastabend CP, Dzieciuchowicz L, Marston W, Vedantham S, Ting W, Iafrati MD. Venography versus intravascular ultrasound for diagnosing and treating iliofemoral vein obstruction. J Vasc Surg Venous Lymphat Disord. 2017 Sep;5(5):678-687. doi: 10.1016/j.jvsv.2017.04.007. Epub 2017 Jun 28.
Other Identifiers
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007-13
Identifier Type: -
Identifier Source: org_study_id
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