Miracor Medical’s PICSO-AMI-V Randomized Study Begins Enrollment

March 29, 2022—Miracor Medical SA, which is based in Belgium, announced that the first patient was enrolled in the PICSO-AMI-V study to evaluate the company’s PiCSO—pressure-controlled intermittent coronary sinus occlusion—therapy as an adjunct to conventional primary percutaneous coronary intervention (PCI) for patients presenting with inferior ST-elevation myocardial infarction (STEMI).

According to Miracor, PICSO-AMI-V is a prospective, randomized, multicenter feasibility study that will enroll 75 inferior STEMI patients presenting with thrombolysis in myocardial infarction grade 0 and 1 flow at up to 10 clinical sites in Europe.

In the study, patients will be randomized 2:1 to a group receiving PiCSO as an adjunct to their primary PCI procedure versus a group receiving a conventional primary PCI alone. The study’s primary endpoint is adverse device effect rate at 30 days post index procedure. Investigators will also assess cardiac function and clinical safety endpoints—including death, heart failure-related hospitalization, and new onset or worsening of heart failure. The patients will be followed for 1 year.

The first patient was treated at the University Hospital of Toulouse, France, by the team of Professor Didier Carrié, MD. Prof. Carrié commented in the press release, “Our team started using the PiCSO therapy for anterior STEMI patients in 2021. We are delighted to explore new indications and now start using PiCSO for inferior STEMI patients in the context of the PiCSO-AMI-V study.”

The Principal Investigator of the PICSO-AMI-V study is Professor Adrian Banning, MD, of Oxford Heart Center in Oxford, United Kingdom.

“We are pleased to be initiating the PiCSO-AMI-V study,” commented Prof. Banning in the company’s press release. “It will explore the potential for PiCSO therapy to improve the outcomes of patients with heart attacks affecting the inferior side of the heart.”

Prof. Banning continued, “The study builds upon the data from the first-in-man study that we published in 2021. We know that improving outcomes for patients with large heart attacks remains an important unmet need, especially because these patients often progress to develop heart failure.” The first-in-human study was published by Roberto Scarsini MD, et al in Catheterization and Cardiovascular Interventions (2022;99:329-339).

The company stated that PiCSO therapy is used during the primary PCI procedure in acute myocardial infarct. Via its differentiated mechanism of action, Miracor Medical’s PiCSO Impulse system clears the coronary microcirculation by intermittently occluding the coronary sinus outflow.

The PiCSO Impulse system is designed to reduce infarct size, improve cardiac function, and potentially reduce the onset of heart failure following acute myocardial infarction. The device is commercially available for anterior STEMI patients in the European Union, United Kingdom, and the European Free Trade Association. It is not commercially available for inferior STEMI patients, advised the company.