Brief summary

The objective of PiCSO-AMI-I study is to assess efficacy and safety of Pressurecontrolled intermittent Coronary Sinus Occlusion (PiCSO) therapy started post flow restoration but prior to stenting during percutaneous coronary intervention (PCI) compared to standard PCI in the setting of acute STsegment elevation anterior myocardial infarction (STEMI).

Primary endpoints

• Difference in myocardial infarct size (extent of myocardial necrosis quantified by delayed gadolinium enhancement presented as a percentage of LV mass) between the PiCSO Group and the Control Group, assessed by CMR at 5 days post index PCI
• Major Adverse Cardiac Events at 30 days as well as 6 months and 1, 2 and 3 years post index PCI

CERC Services

Regulatory submissions,

CEC, DSMB

CoreLab activities

Countries

United Kingdom, France, Switzerland

Center number

7 investigational centers