Objectives: The coarctation of the aorta stent trial (COAST) is a pivotal trial of the NuMED Cheatham Platinum Stent(®) for treatment of coarctation of the aorta (CoA).
Background: CoA is a congenital obstruction to flow through the aorta. Stents have been used since the 1990s to treat CoA; none have been approved by the Food and Drug Administration for this indication.
Background: Coarctation of the aorta (CoA) accounts for 4% to 5% of congenital cardiac abnormalities. Stent therapy has become an accepted alternative to surgery for older children and adults, although there are no balloon-expandable stents approved by the Food and Drug Administration for use in the aorta. The Cheatham-Platinum (CP) stent was designed for CoA therapy and is widely used outside the United States.
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