A special session at a recent TCT (Transcatheter Cardiovascular Therapeutics) meeting addressed the question of how to design clinical trials in interventional cardiovascular medicine in an era where new therapies offer incremental gains. The pitfalls of using composite endpoints in studies were discussed in the context of the ISCHEMIA trial, which added additional “soft” endpoints late in the design phase. The program session also discussed the feasibility of sham-controlled trials for medical devices.¬† (tctMD)