Vascular Ultrasound Versus Intravascular Ultrasound for Diagnosing Iliac Vein Obstruction

May-Thurner Syndrome Clinical Trial

— USG-DIVO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02240914
• Other study ID #: IDPC_ 4 2014
• Status: Recruiting
• Phase: N/A
• First received: September 3, 2014
• Last updated: September 13, 2014
• Start date: February 2013
• Est. completion date: December 2014

Study information

• Verified date: September 2014
• Source: Instituto Dante Pazzanese de Cardiologia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cockett Syndrome
• Iliac Vein Obstruction
• May-Thurner Syndrome
• Syndrome

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese de Cardiologia	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Fabio H Rossi	Fundação de Amparo à Pesquisa do Estado de São Paulo, Instituto Dante Pazzanese de Cardiologia

Country where clinical trial is conducted

Brazil, 

References & Publications (12)

Cockett FB, Thomas ML. The iliac compression syndrome. Br J Surg. 1965 Oct;52(10):816-21. — View Citation

Etufugh CN, Phillips TJ. Venous ulcers. Clin Dermatol. 2007 Jan-Feb;25(1):121-30. Review. — View 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. Epub 2007 May 30. — View Citation

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. — View Citation

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

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. — View Citation

MAY R, THURNER J. The cause of the predominantly sinistral occurrence of thrombosis of the pelvic veins. Angiology. 1957 Oct;8(5):419-27. — View Citation

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. — View Citation

Neglén P, Raju S. Intravascular ultrasound scan evaluation of the obstructed vein. J Vasc Surg. 2002 Apr;35(4):694-700. — View Citation

Rafael D. Malgor, MD, Demetri Adrahtas, MD, Georgios Spentzouris, MD, Antonios P. Gasparis, MD, Apostolos K. Tassiopoulos, MD, and Nicos Labropoulos.The role of duplex ultrasound in the workup of pelvic congestion syndrome. Journal of Vascular Surgery, 2

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. Epub 2006 Aug 22. — View Citation

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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes