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

Inclusion Criteria:

• Patients with a presence of native or recurrent coarctation of the aorta as confirmed by blood pressure gradient, 2D-echocardiography with Doppler or angiography.
• Subject weighs a minimum of 30 kg.
• The peak pressure gradient is ≥20 mmHg systolic blood pressure across the coarctation site.
• Vessels at access site can accept a minimum size of 9 French for a 12 mm balloon and 11 French for a 14 and 16 mm balloon.
• Coarctation can be successfully crossed with a guide wire, sheath and device.
• Diameter of transverse arch distal to left subclavian artery is between 9.5 mm and 20 mm in diameter.
• Subject is able and willing to adhere to all required follow-up visits and testing.
• Subject is able and willing to adhere to the required follow-up medication regimen.

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, 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.