Coarctation of the aorta stent trial (coast): study design and rationale
American Heart Journal, 06/26/2012
Ringel RE et al. – To ascertain the effectiveness and safety of an interventional device, randomized controlled trials have been offered as the criterion standard. However, these trials are not well suited to study rare conditions such as CoA, especially once the therapy in question has received acceptance within the medical community. New clinical trial and statistical approaches are needed to evaluate such therapies. The COAST study is an example of this kind of innovative trial design.