Vascular Ultrasound Versus Intravascular Ultrasound for Diagnosing Iliac Vein Obstruction

NCT02240914 | Unknown DMC

• 1 other identifier: IDPC_ 4 2014
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Iliac Vein Obstruction; May-Thurner Syndrome; Cockett Syndrome

Keywords

Iliac Vein Obstruction; May-Thurner Syndrome; Cockett Syndrome; Vascular Ultrasound; IVUS

Outcome Measures

Primary Outcomes (1)

• A composite of direct and indirect ultrasonographic signs as a measure of iliac vein stenosis

  • 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.

  within 15 days

Study Arms (1)

Vascular USG and IVUS imaging diagnosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with iliac compression disease CEAP classification 3-6.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fabio H Rossi: lead
• Instituto Dante Pazzanese de Cardiologia: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, 04012-909, Brazil

RECRUITING

Related Publications (14)

• 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.

  PMID: 13478912 BACKGROUND

• 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.

  PMID: 5828716 BACKGROUND

• 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.

  PMID: 21215568 BACKGROUND

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

  PMID: 17276209 BACKGROUND

• 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.

  PMID: 11918875 BACKGROUND

• 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.

  PMID: 17592051 BACKGROUND

• 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.

  PMID: 11932665 BACKGROUND

• 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.

  PMID: 17540535 BACKGROUND

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

  RESULT

• 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.

  PMID: 26992966 RESULT

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

  PMID: 23482553 RESULT

• 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.

  PMID: 16926084 RESULT

• Metzger PB, Rossi FH, Fernandez MG, de Carvalho SFC, Metzger SL, Izukawa NM, Kambara AM, Thorpe P. Association between the degree of iliac venous outflow obstruction by intravascular ultrasound and lower limb venous reflux. J Vasc Surg Venous Lymphat Disord. 2023 Sep;11(5):1004-1013.e1. doi: 10.1016/j.jvsv.2023.05.018. Epub 2023 Jun 21.

  PMID: 37353155 DERIVED

• 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.

  PMID: 26946891 DERIVED

MeSH Terms

Conditions

May-Thurner Syndrome

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Peripheral Vascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Patrick B Metzger, MD

  Vascular Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 16, 2014
• Study Start: February 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

BR (1)