PICANTE Trial Evaluating the Safety and Effectiveness of the KARDION Cory P4 Mechanical Circulatory Support System in Adults Undergoing High-Risk PCI for Coronary Artery Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the KARDION Cory P4 System in adults aged 18 to 90 years who require hemodynamic support during high-risk percutaneous coronary intervention PCI procedures for coronary artery disease. The trial aims to demonstrate outcomes within 30 days after the procedure, focusing on major adverse cardiac and cerebrovascular events MACCE and device-related safety. Participants are randomly assigned to receive one of two types of percutaneous mechanical circulatory support devices during the PCI procedure. The study compares the KARDION Cory P4 System with a commercial control device. Treatment is provided during the index PCI procedure, and follow-up continues for 30 days to assess technical and procedural success as well as any device-related adverse events. During the study, participants undergo evaluations including safety monitoring and outcome assessments up to 30 days post-procedure. Researchers measure device-related safety, major adverse cardiac events, death, and other health outcomes related to the intervention. Participants must comply with follow-up visits and evaluations as specified in the study protocol. The total participation duration includes the procedure and a 30-day follow-up period.

PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm