Venogram vs. Intravascular Ultrasound (IVUS) for Diagnosing Iliac Vein Obstruction
- Conditions
- Iliac Venous Compression
- Registration Number
- NCT02142062
- Lead Sponsor
- Volcano Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. 6 month 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
University of Alabama
๐บ๐ธBirmingham, Alabama, United States
Vein Center of Southwest Louisiana/Imperial Health
๐บ๐ธLake Charles, Louisiana, United States
Washington University School of Medicine
๐บ๐ธSt Louis, Missouri, United States
The Mount Sinai Medical Center
๐บ๐ธNew York, New York, United States
St Thomas Hospital
๐ฌ๐งLondon, United Kingdom
Allegheny Vein and Vascular Clinic
๐บ๐ธBradford, Pennsylvania, United States
SUNY Stony Brook University Medical Center
๐บ๐ธStonybrook, New York, United States
University of North Carolina Hospital
๐บ๐ธChapel Hill, North Carolina, United States
Arizona Heart
๐บ๐ธPhoenix, Arizona, United States
Southern CT Vascular Center
๐บ๐ธBridgeport, Connecticut, United States
Norwalk Hospital
๐บ๐ธNorwalk, Connecticut, United States
Tufts Medical Center
๐บ๐ธBoston, Massachusetts, United States
Hesperia Hospital
๐ฎ๐นModena, Italy
Szpital Kliniczny Przemienienia Paลskiego
๐ต๐ฑPoznan, Poland