Aims: The Svelte Stent Integrated Delivery System (IDS) is a novel fixed-wire thin-strut cobalt-chromium stent characterised by a very low entry profile. The aim of the present study is to evaluate the safety and the feasibility of the Svelte stent IDS implantation in humans.
Methods and results: The present investigation is a prospective, multicentre non-randomised single-arm study. The primary endpoint was freedom from major adverse cardiac events (MACE) at 30 days post-procedure. Invasive follow-up was scheduled at six months post implantation. A total of 47 patients were enrolled and serial OCT imaging was performed in a subgroup of 18 patients. At the index procedure the lesion success rate was 97.9% (46 patients), the mean acute gain was 1.56 +/- 0.43 mm with a mean minimum lumen diameter of 2.48 +/- 0.43 mm Post-implantation OCT imaging revealed a minimal mean prolapse area (0.10 +/- 0.06 mm(2)), mean incomplete stent apposition area (0.12 +/- 0.13 mm(2)) and mean intraluminal mass area (0.05 +/- 0.03 mm(2)). Edge dissections were reported in eight cases (mean dissection width 0.17 +/- 0.07 mm proximally and 0.25 +/- 0.24 mm distally). At 30-day clinical follow-up, one case of myocardial infarction was reported. At six months, the angiographic mean in-stent late loss was 0.95 +/- 0.76 mm By OCT, a high percentage of struts was covered (97.6 +/- 15.00 %) with a mean neointimal thickness of 0.31 +/- 0.14 mm, all edge dissections were clinically silent and healed. Target lesion revascularisation (TLR) occurred in 11 patients (23.4%) and clinically driven TLR in three of these patients (6.4%). No cases of death or stent thrombosis were reported during the study.
Conclusions: Implantation of the Svelte stent IDS was observed to be safe, feasible and associated with a low acute vascular injury and a high percentage of strut coverage at 6-month follow-up.