Vascular Ultrasound Versus Intravascular Ultrasound for Diagnosing Iliac Vein Obstruction

Overview

– Determine the sensitivity, specificity and accuracy of vascular ultrasound, using direct and indirect ultrasonographic signs, in the obstructive diseases of iliac venous segment, in patients with advanced chronic venous insufficiency (CEAP 3-6), considering the intravascular ultrasound (IVUS) as the gold standard for this diagnosis. – Develop an algorithm for noninvasive ultrasound investigation of obstructive lesions in the iliac segment in patients with advanced chronic venous insufficiency (CEAP 3-6).

Full Title of Study: “Prospective, Single-arm, Single Center, Pilot Study of Vascular Ultrasound Imaging Used as an Adjunct to Intravascular Ultrasound for Diagnosing Iliac Vein Obstruction”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2014

Arms, Groups and Cohorts

  • Vascular USG and IVUS imaging diagnosis

Clinical Trial Outcome Measures

Primary Measures

  • A composite of direct and indirect ultrasonographic signs as a measure of iliac vein stenosis
    • Time Frame: within 15 days
    • • 50 patients with Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) classification C3-6 undergoing iliac and common femoral vascular ultrasound imaging with intention to detect significative iliac vein obstructions ( > 50%) and this results will be compared with the gold standard method – IVUS. Primary Endpoints: venous imaging in B- mode, volume flow and expiratory velocity in femoral vein, and the velocity relation before and through the stenosis provided by vascular ultrasound will be analyzed. Venous IVUS will provide measurements of minimum and maximum diameter reduction due to iliofemoral venous obstruction/compression; cross-sectional area reduction will also be measured. The percentage of significant stenosis detected at various thresholds [ < 50%, 50-80%,> 80%] 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Advanced Chronic Venous Insufficiency (CEAP 3-6) submitted to clinical treatment for at least 1 year with no response. – Subject must be > 18 and < 80 years of age – Willing to participate in and able to understand, read and sign the informed consent document before the planned procedure – On duplex ultrasound: patent common femoral vein, and patent deep femoral vein, and/or femoral vein of the study leg 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 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 – 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 – Lower Extremity Arterial Insufficiency – 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fabio H Rossi
  • Collaborator
    • Instituto Dante Pazzanese de Cardiologia
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Fabio H Rossi, PHD – Instituto Dante Pazzanese de Cardiologia
  • Overall Official(s)
    • Patrick B Metzger, MD, Principal Investigator, Vascular Surgeon

References

MAY R, THURNER J. The cause of the predominantly sinistral occurrence of thrombosis of the pelvic veins. Angiology. 1957 Oct;8(5):419-27. doi: 10.1177/000331975700800505. No abstract available.

Cockett FB, Thomas ML. The iliac compression syndrome. Br J Surg. 1965 Oct;52(10):816-21. doi: 10.1002/bjs.1800521028. No abstract available.

Marston W, Fish D, Unger J, Keagy B. Incidence of and risk factors for iliocaval venous obstruction in patients with active or healed venous leg ulcers. J Vasc Surg. 2011 May;53(5):1303-8. doi: 10.1016/j.jvs.2010.10.120. Epub 2011 Jan 7.

Etufugh CN, Phillips TJ. Venous ulcers. Clin Dermatol. 2007 Jan-Feb;25(1):121-30. doi: 10.1016/j.clindermatol.2006.09.004.

McGuckin M, Waterman R, Brooks J, Cherry G, Porten L, Hurley S, Kerstein MD. Validation of venous leg ulcer guidelines in the United States and United Kingdom. Am J Surg. 2002 Feb;183(2):132-7. doi: 10.1016/s0002-9610(01)00856-x.

Lin EP, Bhatt S, Rubens D, Dogra VS. The importance of monophasic Doppler waveforms in the common femoral vein: a retrospective study. J Ultrasound Med. 2007 Jul;26(7):885-91. doi: 10.7863/jum.2007.26.7.885.

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.

Labropoulos N, Borge M, Pierce K, Pappas PJ. Criteria for defining significant central vein stenosis with duplex ultrasound. J Vasc Surg. 2007 Jul;46(1):101-7. doi: 10.1016/j.jvs.2007.02.062. Epub 2007 May 30.

Citations Reporting on Results

Virchow R. Uber die erweiterung kleiner gefasse. Arch Path Anat. 1851; 3:427.

Malgor RD, Adrahtas D, Spentzouris G, Gasparis AP, Tassiopoulos AK, Labropoulos N. The role of duplex ultrasound in the workup of pelvic congestion syndrome. J Vasc Surg Venous Lymphat Disord. 2014 Jan;2(1):34-8. doi: 10.1016/j.jvsv.2013.06.004. Epub 2013 Sep 24.

Malgor RD, Labropoulos N. Diagnosis of venous disease with duplex ultrasound. Phlebology. 2013 Mar;28 Suppl 1:158-61. doi: 10.1177/0268355513476653.

Raju S, Hollis K, Neglen P. Obstructive lesions of the inferior vena cava: clinical features and endovenous treatment. J Vasc Surg. 2006 Oct;44(4):820-7. doi: 10.1016/j.jvs.2006.05.054. Epub 2006 Aug 22.

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