One-size-fits-all strategy in carotid artery treatment using CGuard stent, feasibility and clinical pilot study.

Abstract

<h4>Purpose</h4>Conventionally, the treatment of carotid artery disease customizes stents to the vessel diameter. The design of the CGuard stent and its nitinol shape memory allow for a wide operational range and minimal residual radial force. This pilot study assesses the feasibility and clinical outcomes of the 10-mm CGuard stent in a one-size-fits-all sizes protocol.<h4>Materials and methods</h4>The study is a multicenter, prospective cohort study involving 226 consecutive patients with symptomatic or asymptomatic carotid artery stenosis, with an indication for revascularization. All patients received the 10-mm CGuard stent, irrespective of the carotid artery reference diameter, and were grouped into three categories based on the reference vessel diameter. Endpoints included procedural success and incidence of major adverse cardiovascular events (MACE) at 30 days and 1 year.<h4>Results</h4>The study achieved 100% technical success, with an average residual stenosis of 8.41%. Clinical success was 98.7%. During in-hospital observation, one patient experienced a major ipsilateral stroke (0.4%), and two patients had transient ischemic attacks (TIAs) (0.8%). At the 30-day follow-up, there were one death and one case of re-occlusion which was asymptomatic. No differences between the three groups were found regarding technical or procedural success, residual stenosis, complications, TIAs, MACEs, or patency rates. No events occurred between the 30-day and 1-year follow-up, maintaining the MACE rate at 1.5%. ICA and ECA patency rates at 1 year were 99% and 99.4%, respectively, indicating mid-term treatment effectiveness.<h4>Conclusion</h4>This pilot study demonstrates that the one-size-fits-all approach using a 10-mm CGuard stent to treat carotid artery stenosis provides minimal residual radial force with optimal stent apposition. The one-size-fits-all approach with CGuard stent is feasible, safe, and effective. Further studies for confirmation are guaranteed.