PURPOSE: To evaluate the safety and effectiveness of the Pipeline Embolization Device (PED; ev3/Covidien, Irvine, Calif) in the treatment of complex intracranial aneurysms. MATERIALS AND 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%). CONCLUSION: 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.
PURPOSE: To evaluate the safety and effectiveness of the Pipeline Embolization Device (PED; ev3/Covidien, Irvine, Calif) in the treatment of complex intracranial aneurysms. MATERIALS AND 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%). CONCLUSION: 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: Muhammad Waqas; Kunal Vakharia; Andrew D Gong; Hamid H Rai; Audrey Wack; Najya Fayyaz; Kenneth V Snyder; Jason M Davies; Adnan H Siddiqui; Elad I Levy Journal: Interv Neuroradiol Date: 2019-11-25 Impact factor: 1.610
Authors: M A Möhlenbruch; C Herweh; L Jestaedt; S Stampfl; S Schönenberger; P A Ringleb; M Bendszus; M Pham Journal: AJNR Am J Neuroradiol Date: 2015-02-26 Impact factor: 3.825
Authors: Anass Benomar; Behzad Farzin; David Volders; Guylaine Gevry; Justine Zehr; Robert Fahed; William Boisseau; Jean-Christophe Gentric; Elsa Magro; Lorena Nico; Daniel Roy; Alain Weill; Charbel Mounayer; François Guilbert; Laurent Létourneau-Guillon; Gregory Jacquin; Chiraz Chaalala; Marc Kotowski; Thanh N Nguyen; David Kallmes; Phil White; Tim E Darsaut; Jean Raymond Journal: Neuroradiology Date: 2021-02-24 Impact factor: 2.804
Authors: Arvin R Wali; Charlie C Park; David R Santiago-Dieppa; Florin Vaida; James D Murphy; Alexander A Khalessi Journal: Neurosurg Focus Date: 2017-06 Impact factor: 4.047