Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Volcano Corporation
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
