InspireMD today congratulated the lead investigators on the completion of enrolment in the CREST-2 clinical trials.
The CGuard embolic prevention stent system (EPS), utilising InspireMD’s MicroNet mesh, was included as a device option for stenting in the CREST-2 trials following US Food and Drug Administration (FDA) approval of the company’s investigational device exemption (IDE) supplement application in February 2022. CREST-2 included 23 cases implanted with CGuard.
Marvin Slosman, chief executive officer of InspireMD, stated: “We would like to thank Dr [Brajesh] Lal and the other investigators who are executing this landmark trial, a remarkable achievement in the field of carotid revascularisation and stroke prevention. We are proud to have been the only second-generation investigational device option approved by the FDA for inclusion in the stenting arm of the trial, which we believe reflects the desire of the CREST-2 committee to offer the latest stenting technology. It has been our honour to contribute to this important work.”
Lal (University of Maryland School of Medicine, Baltimore, USA), who is co-principal investigator of the CREST-2 trial, stated: “There continue to be significant advancements in the field of carotid revascularisation and stroke prevention, and information from this study will help determine the optimal treatment for carotid stenosis patients without stroke symptoms. This trial, when complete, will ensure that we remain current with state-of-the-art innovation to achieve the best possible short- and long-term patient outcomes. Along with my fellow investigators, we eagerly await topline results from this important study.”
An InspireMD press release notes that CREST-2 is two independent multicentre, randomised controlled trials of carotid revascularisation and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial randomised patients in a 1:1 ratio to carotid endarterectomy versus no endarterectomy and another randomised patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management is uniform for all randomised treatment groups and is centrally directed.
