title: A novel, self-expanding, nitinol stent in medically refractory intracranial atherosclerotic stenoses: the Wingspan study.
abstract: OBJECTIVE
  The purpose of this study was to assess the safety and performance of the Wingspan stent system and Gateway percutaneous transluminal angioplasty balloon catheter in the treatment of high-grade, intracranial atherosclerotic lesions in patients who had failed medical therapy.
  
  
  METHODS
  In this prospective, multicenter, single-arm study, medically refractory patients with a modified Rankin score < or =3 and recurrent symptoms attributable to angiographically demonstrated intracranial stenosis > or =50% in a vessel 2.5 to 4.5 mm in diameter were enrolled. Intracranial lesions were predilated with an undersized Gateway balloon catheter to 80% of the native vessel diameter, followed by deployment of the self-expanding Wingspan stent to facilitate further remodeling of the atherosclerotic plaque and to maintain vessel patency. Neurologic examinations and angiograms were performed at 6 months after the procedure.
  
  
  RESULTS
  Among the 45 patients enrolled, the degree of stenosis was reduced from a baseline of 74.9+/-9.8% to 31.9+/-13.6% after stenting and 28+/-23.2% at the 6-month follow-up. The 30-day composite ipsilateral stroke/death rate was 4.5% (2/44); at the 6-month follow-up, the ipsilateral stroke/death rate was 7.0%, the rate for all strokes was 9.7%, and all-cause mortality was 2.3%. Physician-reported follow-up in 43 patients (average of 13 months) conducted outside the study protocol (not adjudicated by the clinical event committee) reported 1 additional ipsilateral stroke.
  
  
  CONCLUSIONS
  In medically refractory patients with high-grade intracranial atherosclerotic stenoses, a new treatment paradigm involving predilation with an undersized Gateway percutaneous transluminal angioplasty balloon catheter and placement of a self-expanding Wingspan stent system appears to be safe, may facilitate remodeling, and may contribute to favorable angiographic outcomes.
authors: Lenox Hill Hospital, New York, NY, USA.
authors: Arani
authors: A
authors: Bose
authors: Marius
authors: M
authors: Hartmann
authors: Hans
authors: H
authors: Henkes
authors: Hon Man
authors: HM
authors: Liu
authors: Michael M H
authors: MM
authors: Teng
authors: Istvan
authors: I
authors: Szikora
authors: Ansgar
authors: A
authors: Berlis
authors: Jurgen
authors: J
authors: Reul
authors: Simon C H
authors: SC
authors: Yu
authors: Michael
authors: M
authors: Forsting
authors: Matt
authors: M
authors: Lui
authors: Winston
authors: W
authors: Lim
authors: Siu Po
authors: SP
authors: Sit
mesh_terms: D000368:Aged; D000497:Alloys; D000800:Angioplasty, Balloon; D005260:Female; D006801:Humans; D002537:Intracranial Arteriosclerosis / Q000628:therapy*; D008297:Male; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome
chemical_list: D000497:Alloys; C013616:nitinol