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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venography and IVUS imaging guiding treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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Subjects with iliac compression disease CEAP classification 4-6. Hospitals, venous clinics
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| Name | Affiliation | Role |
|---|---|---|
| Paul Gagne, M.D. | Southern Connecticut Vascular Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35924 | United States | ||
| Arizona Heart |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21536173 | Background | 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. | |
| 17653022 | 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. |
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| Phoenix |
| Arizona |
| 85016 |
| United States |
| Southern CT Vascular Center | Bridgeport | Connecticut | 06614 | United States |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | United States |
| Vein Center of Southwest Louisiana/Imperial Health | Lake Charles | Louisiana | 70601 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| The Mount Sinai Medical Center | New York | New York | 10029 | United States |
| SUNY Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| University of North Carolina Hospital | Chapel Hill | North Carolina | 27599 | United States |
| Allegheny Vein and Vascular Clinic | Bradford | Pennsylvania | 16701 | United States |
| Hesperia Hospital | Modena | Italy |
| Szpital Kliniczny Przemienienia PaĆskiego | Poznan | Poznan | Poland |
| St Thomas Hospital | London | United Kingdom |
| 19474429 | 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. |
| 11932665 | 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. |
| 16828437 | 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. |
| 20557187 | 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. |
| 23433816 | 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. |
| 22018502 | 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. |
| 20875713 | 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. |
| 1750819 | 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. |
| 15622385 | 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. |
| 29033314 | Derived | 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. |
| 28818221 | 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. |