title: The CLEAR-ROAD study: evaluation of a new dual layer micromesh stent system for the carotid artery.
abstract: OBJECTIVE
  The aim of this study was to evaluate the 30-day clinical outcome of treatment using the Roadsaver carotid stent in non-consecutive subjects at high risk for carotid endarterectomy requiring revascularisation.
  
  
  RESULTS
  The CLEAR-ROAD study is a prospective, multinational, single-arm, physician-initiated study planned to include 100 patients in nine centres in Belgium, Italy and Germany. The primary endpoint was the 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any death, stroke or myocardial infarction (MI). The use of embolic protection devices (EPDs) was not mandatory; 31.0% of the patients were symptomatic and in 58.0% of the patients EPDs were used. Technical success was achieved in all cases. The 30-day MAE rate was 2.1% (one patient experienced MI followed by death; another patient experienced a stroke within the first 30 days after procedure). While no statistical analysis could be performed, subgroup data suggested that there were no notable differences in the 30-day MAE rate between symptomatic and asymptomatic patients, or between EPD use.
  
  
  CONCLUSIONS
  The 30-day clinical outcome of 100 patients treated with a dual layer micromesh carotid stent (Roadsaver) shows promising results. The Roadsaver stent is a safe and effective device for endovascular treatment of subjects at high risk for carotid endarterectomy.
authors.affiliation: Department of Vascular Surgery, A.Z. Sint-Blasius, Dendermonde, Belgium.
authors.forename: Marc
authors.initials: M
authors.lastname: Bosiers
authors.forename: Koen
authors.initials: K
authors.lastname: Deloose
authors.forename: Giovanni
authors.initials: G
authors.lastname: Torsello
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.forename: Lieven
authors.initials: L
authors.lastname: Maene
authors.forename: Patrick
authors.initials: P
authors.lastname: Peeters
authors.forename: Stefan
authors.initials: S
authors.lastname: Müller-Hülsbeck
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.forename: Ralf
authors.initials: R
authors.lastname: Langhoff
authors.forename: Michel
authors.initials: M
authors.lastname: Bosiers
authors.forename: Carlo
authors.initials: C
authors.lastname: Setacci
mesh_terms: D000369:Aged, 80 and over; D017130:Angioplasty / Q000379:methods; D017536:Carotid Artery, Common / Q000601:surgery*; D016893:Carotid Stenosis / Q000628:therapy*; D057505:Embolic Protection Devices; D016894:Endarterectomy, Carotid / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000628:therapy*; D011446:Prospective Studies; D011474:Prosthesis Design; D020521:Stroke / Q000628:therapy*; D016896:Treatment Outcome