InspireMD, developer of the CGuard Prime carotid stent system, has announced positive 30-day outcomes from the CGUARDIANS II clinical trial of the CGuard Prime 80cm device for use in transcarotid artery revascularisation (TCAR) procedures.
Key 30-day outcomes observed in the CGUARDIANS II trial include acute device success in 100% (50/50) of patients; no deaths, strokes or myocardial infarctions reported within 30 days; no stent thrombosis within 30 days; and complete stent patency at 30 days in evaluable subjects.
Patrick J Geraghty (Washington University School of Medicine in St Louis, St Louis, USA), co-lead investigator of the CGUARDIANS II study, commented, “The 30-day results observed in the CGUARDIANS II trial suggest that the CGuard Prime 80cm stent may deliver exceptional safety and efficacy when used with a TCAR approach. Notably, the 100% acute device success rate with zero major adverse events has the potential to make CGuard Prime the gold standard implant for high-risk patients undergoing TCAR procedures.”
CGUARDIANS II is a prospective, multicentre, single-arm pivotal study that enrolled 50 patients across 11 trial sites. The objective of the study is to evaluate acute device success and technical success of the CGuard Prime 80 cm when used in conjunction with the US Food and Drug Administration (FDA)-cleared Enroute TCAR neuroprotection system (NPS) in patients considered at high risk for adverse events from carotid endarterectomy.
Earlier this month, InspireMD announced that the first patient had been enrolled in the CGUARDIANS III pivotal study of its SwitchGuard neuroprotection system (NPS) for use with the CGuard Prime 80cm platform in TCAR procedures. The patient was enrolled by Patrick Muck (Good Samaritan Hospital, Cincinnati, USA).
