There is also an outstanding question as to whether or not the results in IVUS are predictive.
This is a terribly noisy measurement, and many of the small trials relying on it have tried to use a single operator to conduct all the measurements.
Using a single operator to make measurements obviously won't fly in a 5000+ patient phase 3 trial. So it is reasonable to ask what real predictive value IVUS provides in translating phase 2 data to phase 3 mortality data.
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