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.
Study Type
OBSERVATIONAL
Enrollment
100
University of Alabama
Birmingham, Alabama, United States
Arizona Heart
Phoenix, Arizona, United States
Southern CT Vascular Center
Bridgeport, Connecticut, United States
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.
Time frame: 6 month
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Norwalk Hospital
Norwalk, Connecticut, United States
Vein Center of Southwest Louisiana/Imperial Health
Lake Charles, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
The Mount Sinai Medical Center
New York, New York, United States
SUNY Stony Brook University Medical Center
Stony Brook, New York, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, United States
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