IPERF-01 is a prospective, interventional, single arm, longitudinal, monocentric clinical investigation. The objective is to assess the safety of the iPerf femoral arterial cannula in patients undergoing a planned cardiac surgery requiring the use of an extracorporeal circulation via a femoral approach for a maximum of 6 hours. A total of 15 subjects will be enrolled in a maximum of 1 study site located in France.
Sponsor
Primary endpoints
Per procedure and late adverse events related to the IPERF Femoral Arterial Cannula, up to 30 days after surgery.
CERC Services
- CEC and DSMB activities
- Clinical trial documentation
- EDC and data management
- Monitoring activities
- Project management
- Safety reporting
- Submission to competent authorities and ethic committees
Countries
France
Number of investigational sites
1
Number of patients
15 (estimation)
