Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary
Design
Guideline
Authors
Discussion
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Member takes
Implication
Staged stent approval may enhance safety data before full market use; extends current CE-mark processes with mandatory randomized trials.
Structured PICO
I
Intervention
Coronary stents evaluation pathway
The ESC-EAPCI task force proposes a new two-stage regulatory pathway for the evaluation and CE-mark approval of coronary stents in Europe.
Cite This Study
Byrne et al. (2015) conducted a review in Evaluation of coronary stents. Two-stage clinical evaluation plan was evaluated. The ESC-EAPCI Task Force recommends a novel two-stage clinical evaluation pathway for coronary stent market approval, including an initial pre-market trial and a subsequent mandatory randomized trial.