German cardiovascular medical device company Protembis has enrolled the first patient in its PROTEMBO investigational device exemption (IDE) pivotal trial of the ProtEmbo System.
The ProtEmbo System is a cerebral embolic protection device used during transcatheter aortic valve replacement (TAVR) procedures.
It aims to offer complete protection for the brain by guarding all cerebral vessels without interfering with TAVR equipment.
The trial will include 250-500 randomised patients across the US and Europe, testing the ProtEmbo System's ability to provide complete three-vessel coverage of the cerebral arteries.
It will compare the system with a hybrid control group, half of whom will receive no cerebral embolic protection and the other half will receive Boston Scientific’s Sentinel CEP, which covers only two of the three cerebral arteries.
The primary efficacy endpoint of the trial will be assessed using diffusion-weighted magnetic resonance imaging (DW-MRI) and an adaptive statistical approach that allows for pre-specified interim analyses.
This could potentially lead to early study completion if the ProtEmbo System demonstrates superiority. The primary safety endpoint will be the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30 days.
Protembis co-CEOs Karl von Mangoldt and Conrad Rasmus said: “We are delighted to announce that the first patient has been enrolled in the trial and that we are executing a cadenced plan to activate the other investigational sites in the next few months.
“We would like to express our gratitude to the teams at the sites for the hard work that each has invested in the study startup phase. This significant progress reflects the close collaboration between our study executive committee, our clinical research organization, and core lab partners in planning this complex trial.”
The PROTEMBO study is being led by global co-principal investigators Dr Susheel Kodali from New York Presbyterian Hospital, Dr Raj Makkar from Cedars Sinai in Los Angeles, US; and Dr Stephan Haussig from Herzzentrum in Dresden, Germany.
Dr Roxana Mehran from Mount Sinai will serve as the chair of the study executive committee.
Last October, the company received approval from the US Food and Drug Administration for the PROTEMBO IDE pivotal trial.
