InspireMD today announced that the first patient has been enrolled in the company’s CGUARDIANS II clinical trial evaluating its CGuard Prime carotid stent system in patients undergoing carotid artery stenting (CAS) via the transcarotid artery revascularisation (TCAR) approach. The patient was enrolled by Patrick Muck at Good Samaritan Hospital, part of the TriHealth System in Cincinnati, USA. Muck serves as both the site principal investigator as well as a co-lead investigator of the CGUARDIANS II study.
CGUARDIANS II is a prospective, multicentre, single-arm pivotal study that aims to enrol a minimum of 50 evaluable patients. The objective of this study is to evaluate acute device success and technical success of the CGuard Prime when used in conjunction with a US Food and Drug Administration (FDA)-cleared TCAR neuroprotection system in patients at high risk for adverse events from carotid endarterectomy.
Marvin Slosman, chief executive officer of InspireMD, commented: “As we approach potential FDA approval of CGuard Prime with a CAS indication in the first half of next year, we are thrilled to have initiated the CGUARDIANS II study that, if successful, will address an ever-expanding TCAR market of roughly 30,000 procedures performed in the USA this year. I would like to thank Dr Muck for helping us achieve this initial and critical enrolment milestone, and I look forward to the efficient execution of this important study as we work to enable the use of CGuard Prime in the broadest application, offering patients and physicians this next-generation stenting platform, which has demonstrated best-in-class clinical outcomes in rigorous clinical studies and with over 60,000 devices sold to date.”
Muck, who is programme director and chief of vascular surgery at Good Samaritan Hospital, stated: “As we begin this study of CGuard Prime in a TCAR setting, we value tremendously the prior data from the C-GUARDIANS PMA [premarket approval], the real-world results of this implant and its potential to advance patient care through these unmatched clinical results. The protective qualities of the MicroNet mesh offer patients the sustainable protection which is so important in both short- and long-term outcomes of this procedure. We look forward to the efficient enrolment of this study, contribution from the team of investigators and working with InspireMD on this important programme.”
