Miracor Medical, a Belgian medical device company, has announced the initiation and enrolment of first patient in the PICSO-AMI-I study to evaluate the benefits of PiCSO therapy, in comparison with conventional PCI for the treatment of anterior STEMI patients.
Miracor said that the principal investigator of the study, Professor Adrian Banning is treating the first patient enrolled into the study, at the Oxford Heart Centre, Oxford, UK.
The PICSO-AMI-I is a prospective, randomized, double-arm, multi-centre study that enrols 144 patients recognised with anterior STEMI at 9 clinical sites in Western Europe.
In addition, the study is designed to demonstrate the advantage of using PiCSO in combination with PCI, in reducing infarct size measured by CMR at 5 days, in comparison with a conventional strategy of PCI alone.
Banning said: “We are delighted to be initiating the PiCSO-AMI-I study. This study will explore the potential for PiCSO therapy to significantly improve the care of patients with larger heart attacks. My group and I have treated over 30 patients with the PiCSO therapy and we are excited to start this important randomized study, which builds upon the existing registry data.
“Improving outcomes for patients with large heart attacks is an important challenge and is an important unmet need currently. With this trial we hope to help define the long-term impact and benefits of the PiCSO therapy.”
The secondary efficacy endpoints of the study include MVO and cardiac function at 5 days and 6 months, and secondary clinical endpoints include death, heart failure-related hospitalization, new onset or worsening of heart failure.
Under the PiCSO therapy, the clinical endpoints are followed up annually for 3 years, and the therapy has shown positive results in several clinical studies.
The data from two recent studies showed that the use of the PiCSO Impulse System is associated with a significant infarct size reduction, where the OxAMI-PICSO study showed an early improvement of coronary microvascular function post PiCSO treatment
PiCSO therapy is set to accelerate the microcirculatory recovery and help significantly lower Index of Microcirculatory Resistance (IMR) at 24-48 hours when compared to controls leading to overall infarct size reduction.
Miracor Medical CEO Olivier Delporte said: “We are thrilled to start this randomized clinical trial in Europe, and to include world-leading institutions in our clinical investigation. This study is designed to provide the definitive proof of the clinical benefit of PiCSO over conventional standard of care for STEMI patients, and has the potential to bring PiCSO to guidelines for the treatment of this STEMI patient population.”