Venogram vs. Intravascular Ultrasound (IVUS) for Diagnosing Iliac Vein Obstruction

NCT02142062 | Completed

• 1 other identifier: 007-13
• Study Type: observational
• Target: 100
• Locations: 4 countries
• Sites: 14

Brief Summary

The purpose of this study is to demonstrate that IVUS identifies more instances of significant iliac and common femoral vein outflow obstruction than multiplanar venography.No hypothesis testing is planned.

Conditions

Iliac Venous Compression

Keywords

Venous outflow obstruction; Iliac Vein; Common Femoral Vein; Iliac Compression

Outcome Measures

Primary Outcomes (1)

• 100 patients with Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) classification C4-6 undergoing iliac and common femoral and venography with intention to treat venous outflow obstruction.

  Primary Endpoints: Both venous IVUS and traditional venography will provide measurements of minimum and maximum diameter reduction due to iliofemoral venous obstruction/compression; cross-sectional area reduction will also be measured by IVUS, and calculated for venography (from min. and max. diameters, assuming elliptical cross-section6). The diameters and cross-sectional area are compared to adjacent reference vessel in order to calculate the degree of stenosis. The percentage of significant stenosis detected at various thresholds \[e.g., 50%, 60%, 70%, 80%, for diameter reduction, and (separately) for area reduction\] 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. In addition to the binary outcome of significant stenosis, the numeric values for diameters and cross-sectional areas will be compared.

  6 month

Study Arms (1)

Venography and IVUS imaging guiding treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with iliac compression disease CEAP classification 4-6. Hospitals, venous clinics

You may qualify if:

• Subject must be \> 18 and \< 85 years of age
• 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

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 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.

Sponsors & Collaborators

• Volcano Corporation: lead

Study Sites (14)

University of Alabama

Birmingham, Alabama, 35924, United States

Location

Arizona Heart

Phoenix, Arizona, 85016, United States

Location

Southern CT Vascular Center

Bridgeport, Connecticut, 06614, United States

Location

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

Vein Center of Southwest Louisiana/Imperial Health

Lake Charles, Louisiana, 70601, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

The Mount Sinai Medical Center

New York, New York, 10029, United States

Location

SUNY Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

University of North Carolina Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Allegheny Vein and Vascular Clinic

Bradford, Pennsylvania, 16701, United States

Location

Hesperia Hospital

Modena, Italy

Location

Szpital Kliniczny Przemienienia Pańskiego

Poznan, Poznan, Poland

Location

St Thomas Hospital

London, United Kingdom

Location

Related Publications (13)

• 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.

  PMID: 21536173 BACKGROUND

• 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.

  PMID: 17653022 BACKGROUND

• 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.

  PMID: 19474429 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

• 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.

  PMID: 16828437 BACKGROUND

• 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.

  PMID: 20557187 BACKGROUND

• 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.

  PMID: 23433816 BACKGROUND

• 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.

  PMID: 22018502 BACKGROUND

• 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.

  PMID: 20875713 BACKGROUND

• 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.

  PMID: 1750819 BACKGROUND

• 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.

  PMID: 15622385 BACKGROUND

• 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.

  PMID: 29033314 DERIVED

• 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.

  PMID: 28818221 DERIVED

Study Officials

• Paul Gagne, M.D.

  Southern Connecticut Vascular Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 20, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

PL (1); IT (1); US (11); GB (1)