Recommendations
11.7	Describe outcomes in CLTI trials using a combination of objective and clinically relevant events, subjective PROMs and HRQL assessments, and anatomic and hemodynamic end points.
11.8	Require regulatory trials aimed at obtaining premarket approval for devices for use in CLTI to study CLTI patients and to present data on objective and clinically relevant end points, PROMs and HRQL assessments, and anatomic and hemodynamic end points.