Clinical trial NCT02240914: Vascular Ultrasound Versus Intravascular Ultrasound for Diagnosing Iliac Vein Obstruction
Official title: 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: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iliac Vein Obstruction
May-Thurner Syndrome
Cockett Syndrome
Keywords: Iliac Vein Obstruction
May-Thurner Syndrome
Cockett Syndrome
Vascular Ultrasound
IVUS
Lead sponsor: Instituto Dante Pazzanese de Cardiologia
Sponsor class: OTHER
Collaborators: name: Instituto Dante Pazzanese de Cardiologia
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with iliac compression disease CEAP classification 3-6.

Brief summary: * 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).


Eligibility criteria: 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.

Primary outcomes:
measure: A composite of direct and indirect ultrasonographic signs as a measure of iliac vein stenosis
timeFrame: within 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
Study officials:
affiliation: Vascular Surgeon
name: Patrick B Metzger, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
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citation: 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.
citation: Malgor RD, Labropoulos N. Diagnosis of venous disease with duplex ultrasound. Phlebology. 2013 Mar;28 Suppl 1:158-61. doi: 10.1177/0268355513476653.
citation: 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.
citation: Metzger PB, Rossi FH, Kambara AM, Izukawa NM, Saleh MH, Pinto IM, Amorim JE, Thorpe PE. Criteria for detecting significant chronic iliac venous obstructions with duplex ultrasound. J Vasc Surg Venous Lymphat Disord. 2016 Jan;4(1):18-27. doi: 10.1016/j.jvsv.2015.07.002. Epub 2015 Sep 12.