Claret Medical’s Sentinal clot snare misses primary efficacy endpoint
The Sentinel embolic protection device made by Claret Medical met its safety endpoint but missed the efficacy endpoint in a trial of high-risk patients.
The Sentinel device uses a pair of filters, placed in the right radial or brachial arteries before TAVR and retrieved after valve placement, that are designed to trap blood clots before they get to the brain. The 360-patient Sentinel trial had a primary safety endpoint of major adverse cardiac and cerebrovascular events at 30 days and a primary efficacy endpoint of reduction in median new lesion volume in protected territories, assessed by MRI at 2 to 7 days.
Patients were randomized 1:1:1 to either treatment using Sentinel during TAVR and 2 imaging cohorts for TAVR with or without the Sentinel device. The rate of MACCE was 7.3% in both arms that used the Claret Medical device and 9.9% in the control arm, for no statistically significant difference. The rate of all strokes at 30 days was likewise not significantly different at 5.6% in the device arms and 9.1 in the control group. The median total new lesion volume in protected territories was 102.8mm3 for the Sential cohorts, compared with 178.0mm3 for the just-TAVR group.
Important confounders included transcatheter valve type and baseline MRI lesion volume (a marker for baseline cerebral disease burden). After adjusting for these factors, embolic protection resulted in reduction of new lesion volume on MRI, but there was no significant improvement in neurocognitive function associated with embolic protection.
“Despite not meeting its primary efficacy endpoint, the study does provide evidence of device safety and confirms the high-frequency of embolic debris capture with the Sentinel dual filter neuroprotection therapy,” co-principal investigator Dr. Susheel Kodali, of the New York-Presbyterian Hospital/Columbia University Medical Center, said in prepared remarks. “In addition, there are important lessons from this trial which should impact future research on neuroprotection during TAVR.”
“We are gratified that our commitment to science and clinical trial excellence has enabled us to make TAVR a safer procedure and shed light on an important new risk factor in further validating the role of cerebral protection in TAVR,” Claret Medical president & CEO Azin Parhizgar said. “Following our recent marketing application submission, we look forward to working with the FDA to make the Sentinel CPS available to American physicians and their patients who want protection during TAVR.”