InspireMD CGuard Carotid Stent Approved for Inclusion in the CREST-2 Trial

February 28, 2022—InspireMD, Inc. announced that the company’s CGuard carotid stent with MicroNet mesh will be included as a device option for stenting in the CREST-2 trial. Last week, the FDA approved the investigational device exemption supplement application for CREST-2 to include the CGuard. InspireMD will now evaluate strategic sites to enable expedited access.

According to InspireMD, the CREST-2 study first enrolled patients in 2014 as two parallel multicenter, randomized, observer-blinded endpoint clinical trials to determine the best way to prevent strokes in patients with high-grade carotid stenosis but no stroke symptoms related to that blockage. The trial will enroll an estimated 2,480 patients who will remain in the study for 4 years after the start of intervention.

Thomas Brott, MD, is Principal Investigator of CREST-2, which is sponsored by the National Institute of Neurological Disorders and Stroke.

“The CREST-2 Executive Committee is keenly focused on positioning the results of the trial to be relevant, actionable, and informative to contemporary practices,” commented Dr. Brott in the InspireMD press release. “Over the course of the trial, we have continually introduced state-of-the-art medical, pharmacological therapies to reduce the risk of stroke in our randomized patient population. It is critical of any long-term study to remain aligned with evolving technology and relevant devices.”

Dr. Brott continued, “After examining the extensive clinical experience with the CGuard stent and the large body of evidence to its effectiveness, the study executive committee felt it appropriate to include this stent as a treatment option. Patients that agree to participate in the CREST-2 trial, depending on accessibility and operator training and discretion, will now have access to this state-of-the-art carotid stent device.”

The company noted that the trial is being conducted in the United States, Canada, Spain, Israel, and Australia. Physician investigators in the trial have been carefully selected on their ability to perform revascularization at low risk. Another key component of the trial is that important stroke risk factors, including hypertension, diabetes, high cholesterol, cigarette smoking, physical activity, and diet, are managed intensively. More information on CREST-2 is available at the FDA’s clinicaltrials.gov.