Table 1.
Study eligibility criteria
Inclusion criteria | |
Aged between 18 and 80 years | |
Reflux in the great saphenous vein of > 0.5 s | |
Diameter of the saphenous vein between 2 and 20 mm (standing position) | |
One or more of the symptoms related to the incompetent saphenous vein | |
CEAP classification of C2 through C5 | |
Exclusion criteria | |
Previous treatment in the targeted vein segment | |
Tortuous vein in which the delivery catheter cannot be inserted | |
Aneurysm of target-vein segment of > 20 mm | |
Daily use of narcotic or pain medications to control pain associated with reflux | |
Known hypercoagulable disorder | |
Active malignancy | |
Regular or current use of systemic anticoagulation | |
Previous deep vein thrombosis/pulmonary embolism or active acute superficial thrombophlebitis | |
Unable to comply with the schedule and protocol evaluations | |
Unable to ambulate | |
Unable to provide informed consent | |
Currently pregnant or breastfeeding | |
Known sensitivity to cyanoacrylate adhesives | |
Participation in another clinical study that did not reach the primary endpoint within 30 days prior to enrollment |
CEAP Clinical, Etiologic, Anatomic, and Pathophysiologic