PiCSO-AMI-II US IDE – TRIAL OVERVIEW
A Study to Evaluate the Safety and Efficacy of PiCSO in Anterior STEMI Patients
- To assess the safety and efficacy of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) as adjunct to PCI compared to standard PCI in the setting of acute anterior ST-segment elevation myocardial infarction (STEMI).
- Multicenter, randomized (2 PiCSO :1 Control), controlled, pivotal study to evaluate safety and efficacy of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with acute anterior ST-segment elevation myocardial infarction (STEMI), presenting with TIMI 0, 1 or 2 and symptom duration ≤ 12 hours treated adjunct to percutaneous coronary intervention (PCI) compared to standard PCI.
- In patients presenting with acute myocardial infarction, after flow restoration, the subjects meeting all eligibility criteria will be randomized either to PiCSO Group or Control Group.
- Follow-up visits will take place at day 5, day 30, 6 months, 1 year, 2 years and 3 years. Patients will undergo cardiac magnetic resonance imaging (CMR) assessment at 5 days and 6 months.
- PiCSO device or procedure related adverse events reported through 30 days
- 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±2 days post index PCI.
The study management and site selection are in their formative stage. It is planned to include sites in the USA, Canada, and Europe. To register interest or to receive updates, please complete the form below and we will reach out to you.
To learn more about PiCSO, read the CRM Review Publication:
C.M. Gibson, et al., Pressure-controlled intermittent coronary sinus occlusion: A novel approach to improve microvascular flow and reduce infarct size in STEMI; Cardiovascular Revascularization Medicine