Layers of Evidence

Safety and Efficacy of the CGuard® Carotid Stent System in Carotid Artery Stenting (C-GUARDIANS)

Objective: The authors sought to evaluate the safety and efficacy of the MicroNet-covered stent in treating patients with significant carotid stenosis at high risk of adverse events from carotid endarterectomy.

Conclusion: The C-GUARDIAN trial demonstrated low rates of DSMI through 30 days, and ipsilateral stroke through 1 year. No unexpected adverse device effects or unexpected serious adverse device effects were reported.

Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting (C-GUARDIANS)

Objective: 30-day assessment of the safety and efficacy of the CGuard™ carotid stent system in patients (N=316) at high risk for carotid endarterectomy with  carotid artery stenosis (25% symptomatic).

Conclusion: Treatment with the CGuard™ carotid stent system with embolic protection had a low incidence of stroke, death, or MI post-procedure to 30-day follow-up.

Accumulating long-term evidence for MicroNet^TM-covered stent safety, efficacy, and durability in primary and secondary stroke prevention: 5-year data from the PARADIGM-Extend prospective academic trial

Objective: To evaluate the feasibility and outcome of routine anti-embolic stent system use in unselected, consecutive patients referred for carotid revascularization (all-comers study).

Conclusion: Long-term clinical and duplex ultrasound evidence is consistent with normal healing and sustained safety and stroke prevention efficacy of the MicroNet^TM-covered embolic prevention stent system, which is routinely used, on top of optimized medical therapy, for stroke prevention in symptomatic and increased-stroke-risk asymptomatic subjects with carotid stenosis recommended for revascularization by the NeuroVascular Team.