title: Clinical and angiographic outcomes following first-in-man implantation of a novel thin-strut low-profile fixed-wire stent: the Svelte Coronary Stent Integrated Delivery System first-in-man trial.
abstract: OBJECTIVE
  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.
  
  
  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 mm²), mean incomplete stent apposition area (0.12 ± 0.13 mm²) and mean intraluminal mass area (0.05 ± 0.03 mm²). 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.
authors.affiliation: Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Roberto
authors.initials: R
authors.lastname: Diletti
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.forename: Christos V
authors.initials: CV
authors.lastname: Bourantas
authors.forename: Robert Jan
authors.initials: RJ
authors.lastname: van Geuns
authors.forename: Nicolas M
authors.initials: NM
authors.lastname: Van Mieghem
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Agostoni
authors.forename: Takashi
authors.initials: T
authors.lastname: Muramatsu
authors.forename: Vasim
authors.initials: V
authors.lastname: Farooq
authors.forename: Richard
authors.initials: R
authors.lastname: Spencer
authors.forename: Jean
authors.initials: J
authors.lastname: De Schepper
authors.forename: Mark
authors.initials: M
authors.lastname: Pomeranz
authors.forename: Pieter
authors.initials: P
authors.lastname: Stella
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D000368:Aged; D057785:Catheters; D002858:Chromium Alloys; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: D002858:Chromium Alloys