Initial Clinical Results and In Vitro Testing of the New CGuard MicroNet-Covered "One-Size-Fits-All" Carotid Stent.

To evaluate a MicroNet-covered stent designed for the carotid artery with the new ability to adjust to different vessel diameters. Thirty consecutive patients (mean age 72.1±7.7 years; 26 men) with symptomatic stenosis (86.3%±6.4%) of the internal carotid artery were treated with the new self-adjusting nitinol stent, which has a self-expanding, open-cell design covered by an outer conformable layer (MicroNet). The only stent used was the "One-Size-Fits-All" CGuard stent with lengths of 30 or 40 mm. In bench testing, the chronic outward force of the One-Size-Fits-All stent was determined with a segmented head radial force test device. The stent was deployed directly into the test device at a diameter of 5.0 mm, and the chronic outward force was measured up to 10.0 mm, the maximum expansion of the stent. The stent was successfully implanted in all 30 patients without periprocedural complications, including no neurological events within 30 days. The chronic outward force normalized by stent length demonstrated a near-equivalent radial force outcome: The stent displayed only a minor difference between the minimal radial force at 9.0 mm (0.195 N/mm) and the maximal radial force at 5.5 mm (0.330 N/mm). The new self-adjusting, MicroNet-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.