Cardionovum has announced the enrolment of the first patient in the international Hyper II clinical study designed to evaluate the safety and efficacy at 12 months of the hybrid treatment approach combining the Restore drug-coated balloon (DCB) with new a generation drug-eluting stent (DES) in long diffuse coronary artery disease (CAD).
The first procedure of the Hyper II clinical study was performed on 27 July at Sant’Ambrogio Cardio-Thoracic Center in Milan, Italy by Alfonso Ielasi, principal investigator of the study.
The Restore paclitaxel-coated balloon utilises a unique combination of a rapid absorption drug—paclitaxel—and patented Safepax, paclitaxel coating matrix.
The Hyper II is a prospective, non-randomised, multicentre clinical trial that will enrol up to 500 patients across 15 international sites and is built upon the findings of the Hyper Study presented at the EuroPCR 2022 (17–20 May, Paris, France), showing encouraging clinical results in terms of device-oriented composite endpoint (DoCE) of 3.7% at 12 months with no thrombosis reported in DES and DCB treated segments. The primary endpoint of the Hyper II study has been defined as the target lesion failure (TLF) incidence and will be assessed within 12 months after the index procedure.
“De novo diffuse coronary artery disease still represents an open issue in the field of interventional cardiology,” said Ielasi. “Overlapping DES and DCB in order to limit the total stent length may reduce the risks associated with permanent rigid metallic cages within the coronary wall. This concept could be particularly important in case of very long lesions involving small vessels and in diabetic patients.”
Miquel Craven-Bartle, Capella CEO of Cardionovum, commented: “Following our claim “Life deserves the best”, we are committed to improving patients’ quality of life by providing innovative solutions and clinical evidence for the treatment of cardiovascular disease. We are excited to announce the first procedure in the Hyper II trial and we truly hope that this trial will help generating a larger body of clinical evidence for a better treatment of patients with diffuse coronary artery disease.”