Clinical Trials

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.

A Prospective, Multicenter Study of a Novel Mesh-Covered Carotid Stent: The CGuard™ CARENET Trial (Carotid Embolic Protection Using MicroNet^TM)

Objective: Evaluate the feasibility of the CGuard™ Carotid Embolic Protective Stent system in treating carotid artery lesions in consecutive patients (N=30) suitable for carotid artery stenting.

Conclusion: The CGuard™ system is feasible for patients undergoing carotid artery stenting. In addition, the benefit of using CGuard™ may extend throughout the stent healing period.

Novel PARADIGM in carotid revascularisation: Prospective evaluation of All-comer peRcutaneous cArotiD revascularisation in symptomatic and Increased-risk asymptomatic carotid artery stenosis using CGuard™ MicroNet^TM-covered embolic prevention stent system

Objective: To determine (1) periprocedural and 30-day clinical safety and efficacy of the MicroNet^TM-covered embolic prevention carotid stent system (MN-EPS) in routine use for unselected carotid stenosis (CS) patients undergoing CAS (N=101), as well as (2) feasibility of MN-EPS post-dilatation optimization to minimize residual stenosis after CAS.

Conclusion: These increased-risk consecutive patient data (1) indicate the safety and efficacy of routine MN-EPS use in achieving endovascular reconstruction across all-comer CS lesion subsets and (2) are consistent with MN-EPS protection against cerebral events extending throughout the stent healing period.

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.

Clinical Results and Mechanical Properties of the Carotid CGuard^TM Double-Layered Embolic Prevention Stent

Objective:  A prospective single-center study enrolled 30 consecutive patients with symptomatic (n=25) or high-grade (n=5) internal carotid artery (ICA) stenosis. The goal was to report early clinical outcomes with a novel double-layer stent for the ICA and the in vitro investigation of the stent’s mechanical properties.

Conclusion: Because of its structure, the novel CGuard^TM EPS stent is characterized by high flexibility, a high radial force, and very good plaque coverage. These first clinical results demonstrate a safe implantation behavior without stroke up to 6 months after the procedure.

Initial Clinical Results and In Vitro Testing of the New CGuard^TM MicroNet^TM-Covered “One-Size-Fits-All” Carotid Stent

Objective:  To evaluate a MicroNet^TM-covered stent designed for the carotid artery with the new ability to adjust to different vessel diameters in 30 consecutive patients with symptomatic stenosis (86.3%±6.4%) of the internal carotid artery.

Conclusion: The new self-adjusting, MicroNet^TM-covered stent has high conformability combined with an almost equivalent radial force at expansion diameters ranging from 5.5 to 9.0 mm. The first clinical results demonstrate that the new One-Size-Fits-All stent can be safely implanted in internal carotid arteries with reference diameters within this range.

Prospective multi-specialty evaluation of carotid artery stenting using the CGuard^TM MicroNet^TM-covered Embolic Prevention System in real-world multicentre clinical practice: the IRON-Guard study

Objective: The present study aimed to evaluate periprocedural, 30-day, and 1-year outcomes in a prospective series of patients treated with the CGuard^TM Embolic Prevention System (EPS).

Conclusion: The CGuard^TM MicroNet™ covered embolic prevention stent has proven effective in preventing carotid-related neurological events in both the short-term and midterm.

Prospective Experience on CAS Using the CGuard^TM Stent System: The IRONGUARD 2 Study

Objective: This study aimed to evaluate the 30-day and 1-year safety and efficacy of a dual-layered stent (DLS) for carotid artery stenting (CAS) in a multicenter registry.

Conclusion: This real-world registry suggests that using the CGuard^TM embolic prevention system in clinical practice is safe and associated with minimal adverse neurological events at 30-day follow-up and up to 12-month follow-up.

Randomized Controlled Trial of Conventional Versus MicroNet^TM-Covered Stent in Carotid Artery Revascularization

Objective: The aim of this study was to compare procedure-related ipsilateral cerebral embolism with a conventional (Acculink, Abbott Vascular) versus a MicroNet^TM-covered (CGuard^TM, InspireMD) stent in carotid artery stenting (CAS).

Conclusion: The MicroNet^TM-covered stent significantly reduced periprocedural and abolished postprocedural cerebral embolism compared to a conventional carotid stent. This is consistent with the MicroNet^TM-covered stent’s sustained embolism prevention, which translates into cerebral protection during and after CAS. The present findings may influence decision-making in carotid revascularization.