Early Feasibility Study of the Vivasure PerQseal® Closure Device System After Use of the Impella Device for Cardiogenic Shock or Protected Percutaneous Coronary Intervention
The purpose of this Clinical Investigation Plan is to assess the initial feasibility results of the PerQseal® device, when used on this very specific Impella population. Safety and effectiveness will be assessed in patients where an Impella device was used for either cardiogenic shock or PPCI.
- Device: PPCI
- Device: Cardiogenic shock
- Age ≥ 19 years,
- Use of an Impella CP or 2.5 Impella device via the common femoral artery for protected percutaneous coronary intervention (PPCI) or cardiogenic shock,
- Duration of Impella use > 8 hours and ≤ 4 days if used for cardiogenic shock
- Duration of Impella use ≤ 6 hours if used for PPCI.
- Impella access sheath between 13 and 14 F,
- Potential subject or authorized representative willing and able to provide appropriate study-specific informed consent,
- Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.