Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta

Exclusion Criteria

• •The physician is not able to access the coarctation with standard techniques.
• •Presence of other thoracic aortic arterial lesions or aneurysms requiring treatment within 30 days of the implant procedure.
• •Length of coarctation is greater than 45 mm in length.
• •Connective tissue and genetic disorders, including William, Marfan, Turner, Noonan syndrome.
• •The coarctation has adjacent, acute thrombus.
• •The coarctation was previously treated with a stent.
• •Proximity of the coarctation to an important side branch resulting in crossing of the side branch with the Large Diameter Advanta™ V12 Covered Stent device (e.g. "jailing" of the branch vessel).
• •Subject has a tubular graft, interposition graft, stent graft at or near the coarctation site that would be interfere with delivery, positioning, expansion or stabilization of the Large Diameter Advanta™ V12 Covered Stent
• •Subject has contrast agent hypersensitivity that cannot be adequately premedicated, has a hypersensitivity to stainless steel, expanded polytetrafluoroethylene (ePTFE) or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications.
• •Bloodstream infection
• •Subject is pregnant or breastfeeding.
• •Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
• •The investigator deems the subject to be an inappropriate candidate for the study.
• •Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. NOTE: Subjects who are participating in the long term follow-up phase of a previously investigational and now approved product are not excluded by this criterion.