MISTRAL-C Trial Shows Neurocognitive Benefit of Sentinel Cerebral Protection System during TAVR

14 october 2015

Results presented at TCT 2015 by Dr. Nicholas Van Mieghem

MISTRAL-C Trial Shows Neurocognitive Benefit of Sentinel Cerebral Protection System during TAVR

Claret Medical™, an innovator in cardiovascular cerebral protection, today announced results from the MISTRAL‐C study showing the first definitive cognitive benefit from use of the Sentinel™ Cerebral Protection System (CPS) during transcatheter aortic valve replacement (TAVR). 

Data show that unprotected patients have a statistically significant (p=0.017) worsening in cognition when compared to Sentinel‐ protected patients at five days post‐TAVR, when assessed using the Mini Mental State Exam (MMSE).   

Results from the multi‐center, randomized, controlled MISTRAL‐C study were presented in an oral presentation today at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting by Principal Investigator Nicholas van Mieghem, MD, Thoraxcenter, Erasmus Medical Center, Rotterdam. MISTRAL‐C also validates findings from the landmark CLEAN‐TAVI study that showed the use of a Claret Medical cerebral protection system reduced the number and volume of brain lesions in TAVR patients. 

MISTRAL‐C showed a 52 percent reduction in the median total new lesion volume at five days post‐procedure as assessed using highly sensitive 3‐Tesla brain MRI.  None of the protected patients had National Institute of Health Stroke Scale (NIHSS) deterioration at five days post‐procedure, while five percent of unprotected patients showed deterioration.   MISTRAL‐C studied 65 patients enrolled at four centers in the Netherlands that underwent TAVR using both self‐expanding and balloon‐expandable valves, with and without the use of the Sentinel CPS. The study compared the median total new lesion volume as detected by DW‐MRI at five days post‐procedure to pre‐procedural baseline cerebral scans. It also included a detailed neurological and cognitive assessment of patients five days post‐procedure.  

Click to read the full press release: http://www.claretmedical.com/press_release

« Go back