First patient treated in US pivotal trial of cerebral protection device

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Claret Medical has announced that the first patient has been successfully treated in its SENTINEL trial, which is a US multicenter pivotal trial of its Sentinel cerebral protection system. The landmark trial is the first prospective, randomised, controlled, blinded trial in the US to evaluate the role of cerebral protection during transcatheter aortic valve implantation (TAVI).

A company press release reports that the first patient was treated at New York and Presbyterian Hospital/Columbia University Medical Center by Susheel Kodali, a national co-principal investigator for the trial. It adds that the SENTINEL trial will evaluate up to 284 patients at up to 15 centres nationwide.

The primary endpoints of the study are the reduction in total new lesion volume as determined by diffusion-weighted magnetic resonance imaging (DW-MRI) and major adverse cardiac and cerebrovascular events (MACCE). A number of secondary endpoints, such as neurocognitive and histopathological outcomes during TAVI, will be compared in the study arms with and without cerebral protection.

“Any occurrence of stroke is one too many, and results from this clinical trial may give us the evidence needed to make cerebral protection a standard of care during TAVI, as it is in carotid artery stenting,” said Samir Kapadia, director of the Cleveland Clinic’s Sones Cardiac Catheterization Laboratories and a national co-principal investigator for the study. “By both capturing and removing embolic debris released during TAVI, the Sentinel cerebral protection system may offer a unique neuroprotective benefit. We expect the device to demonstrate a similarly significant reduction in the number and size of lesions in the brains of TAVI patients when cerebral protection is used as was recently reported in the CLEAN-TAVI trial.”