title: Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial.
abstract: OBJECTIVE
  To evaluate the safety and effectiveness of the Pipeline Embolization Device (PED; ev3/Covidien, Irvine, Calif) in the treatment of complex intracranial aneurysms.
  
  
  METHODS
  The Pipeline for Uncoilable or Failed Aneurysms is a multicenter, prospective, interventional, single-arm trial of PED for the treatment of uncoilable or failed aneurysms of the internal carotid artery. Institutional review board approval of the HIPAA-compliant study protocol was obtained from each center. After providing informed consent, 108 patients with recently unruptured large and giant wide-necked aneurysms were enrolled in the study. The primary effectiveness endpoint was angiographic evaluation that demonstrated complete aneurysm occlusion and absence of major stenosis at 180 days. The primary safety endpoint was occurrence of major ipsilateral stroke or neurologic death at 180 days.
  
  
  RESULTS
  PED placement was technically successful in 107 of 108 patients (99.1%). Mean aneurysm size was 18.2 mm; 22 aneurysms (20.4%) were giant (>25 mm). Of the 106 aneurysms, 78 met the study's primary effectiveness endpoint (73.6%; 95% posterior probability interval: 64.4%-81.0%). Six of the 107 patients in the safety cohort experienced a major ipsilateral stroke or neurologic death (5.6%; 95% posterior probability interval: 2.6%-11.7%).
  
  
  CONCLUSIONS
  PED offers a reasonably safe and effective treatment of large or giant intracranial internal carotid artery aneurysms, demonstrated by high rates of complete aneurysm occlusion and low rates of adverse neurologic events; even in aneurysms failing previous alternative treatments.
authors: Neurointerventional Service, Department of Radiology, New York University Medical Center, 560 First Ave, Room HE 208, New York, NY 10016, USA. Tibor.Becske@nyumc.org
authors: Tibor
authors: T
authors: Becske
authors: David F
authors: DF
authors: Kallmes
authors: Isil
authors: I
authors: Saatci
authors: Cameron G
authors: CG
authors: McDougall
authors: István
authors: I
authors: Szikora
authors: Giuseppe
authors: G
authors: Lanzino
authors: Christopher J
authors: CJ
authors: Moran
authors: Henry H
authors: HH
authors: Woo
authors: Demetrius K
authors: DK
authors: Lopes
authors: Aaron L
authors: AL
authors: Berez
authors: Daniel J
authors: DJ
authors: Cher
authors: Adnan H
authors: AH
authors: Siddiqui
authors: Elad I
authors: EI
authors: Levy
authors: Felipe C
authors: FC
authors: Albuquerque
authors: David J
authors: DJ
authors: Fiorella
authors: Zsolt
authors: Z
authors: Berentei
authors: Miklós
authors: M
authors: Marosfoi
authors: Saruhan H
authors: SH
authors: Cekirge
authors: Peter K
authors: PK
authors: Nelson
mesh_terms: D001499:Bayes Theorem; D002343:Carotid Artery, Internal; D002533:Cerebral Angiography; D004621:Embolization, Therapeutic / Q000295:instrumentation*; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D002532:Intracranial Aneurysm / Q000000981:diagnostic imaging / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome; D014481:United States
chemical_list: D010975:Platelet Aggregation Inhibitors