When is a randomized trial necessary to ensure comparison to an appropriate control group?
The panel had mixed views on this question. Dr. Crittenden stated that an RCT was always necessary, whereas Dr. Domanksi suggested that a general rule was not possible. He added that for new concepts and designs, one cannot always use historical data. Dr. Tracy raised the issue of how to define the appropriate control group. Dr. Krucoff said that the answer to the question was a “life cycle” issue and would vary. Question 1b: Please discuss whether adequate trials can be designed with historical controls or objective performance criteria for assessment of this technology. Dr. Dillard commented that the panel had answered the question in its discussion of Question 1a. Question 1c: If a randomized trial is warranted, please discuss whether the control arm should incorporate use of an approved distal protection device. If so, please discuss use of an equivalence hypotheses, rather than a superiority hypothesis, for this study. The panel concurred that the appropriate control is the standa
