InspireMD has announced that its CGuard embolic prevention stent system (EPS) will be included as a device option for stenting in CREST-2 (Carotid revascularisation endarterectomy or stenting trial). Following the recent approval of the CREST-2 investigational device exemption (IDE) supplement application from the US Food and Drug Administration (FDA), the company states that it will be evaluating strategic sites to enable expedited access.
Marvin Slosman, chief executive officer of InspireMD, commented: “This approval for use of CGuard EPS in a trial as significant as CREST-2 is proxy to the validation of our technology platform, contributing to this important work. The CREST-2 trial is widely acknowledged as the most significant ongoing trial to scientifically investigate the optimal course of treatment to prevent strokes for asymptomatic patients with significant carotid disease. The opportunity to be a part of CREST-2 is a tremendous milestone for our company, and we look forward to CGuard playing an important role in the stenting results”.
The study first enrolled patients in 2014, as two parallel multicentre randomised, observer-blinded endpoint clinical trials with the purpose of being to determine the best way to prevent strokes in patients with high-grade carotid stenosis but no stroke symptoms related to that blockage. According to an InspireMD press release, the trial will enrol an estimated 2,480 participants who will remain in the study for four years following the start of intervention.
“The CREST-2 executive committee is keenly focused on positioning the results of the trial to be relevant, actionable, and informative to contemporary practices,” said Thomas Brott (Mayo Clinic, Jacksonville, USA), principal investigator of the National Institute of Neurological Disorders and Stroke (NINDS)-sponsored trial. “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 randomised patient population.
“It is critical of any long-term study to remain aligned with evolving technology and relevant devices. 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.”