The purpose of the clinical investigation is to characterize clinical outcomes and to assess the real-world use of the commercial PALMAZ MULLINS XDâ„¢ Pulmonary Stent.
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Technical Success (Successful use of the study device without additional, unplanned device or procedure-related surgery/re-intervention)
Timeframe: Start time of index procedure through time of discharge/study completion, usually within ~48 hours from end time of index procedure
Patency (Angiographically-determined increase in stented vessel minimum pulmonary artery diameter by ≥ 50% of the pre-stent diameter)
Timeframe: Index procedure (start time to end time)
Safety Outcome (Incidence of Treatment-Emergent Serious Adverse Events)
Timeframe: Time of enrollment (device implant during index procedure) through time of discharge/study completion, usually within ~48 hours from end time of index procedure