Cardionovum Begins HYPER II International Clinical Trial

September 6, 2022—Cardionovum recently announced the enrollment of the first patient in the HYPER II international clinical study, which is designed to evaluate the safety and efficacy at 12 months of a hybrid treatment approach combining the company’s Restore paclitaxel-coated balloon with a new-generation drug-eluting stent (DES) in long diffuse coronary artery disease (CAD).

According to Cardionovum, HYPER II is a prospective, nonrandomized, multicenter clinical trial that will enroll up to 500 patients across 15 international sites. The primary endpoint is the incidence of target lesion failure assessed within 12 months after the index procedure.

The first procedure of the HYPER II study was performed by lead Principal Investigator Alfonso Ielasi, MD, on July 27 at Sant’Ambrogio Cardio-Thoracic Center in Milan, Italy.

“De novo diffuse coronary artery disease still represents an open issue in the field of interventional cardiology,” commented Dr. Ielasi in the company’s press release. “Overlapping DES and drug-coated balloon (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.”

Cardionovum advised that the HYPER II clinical trial is built on the findings of the HYPER study, also led by Dr. Ielasi, which showed encouraging clinical results in terms of device-oriented composite endpoint (3.7% at 12 months), with no thrombosis reported in DES- and DCB-treated segments. The HYPER findings were presented at the EuroPCR 2022 conference held May 17-20 in Paris, France.

The company stated that its Restore paclitaxel-coated balloon uses a unique combination of the rapid-absorption paclitaxel drug and the company’s Safepax paclitaxel coating matrix, which has low wash-off rates.