Pipeline for Uncoilable or Failed Aneurysms: Results from a Multicenter Clinical Trial

Published Online:https://doi.org/10.1148/radiol.13120099

The Pipeline for Uncoilable or Failed Aneurysms study demonstrated a high rate (78 of 108, 73.6%) of complete occlusion of large and giant wide-necked aneurysms of the internal carotid artery and a reasonably low rate of major safety events (6 of 107, 5.6% rate of major stroke or neurologic death).


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.


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%).


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.

© RSNA, 2013


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Article History

Received February 17, 2012; revision requested June 11; revision received October 2; accepted October 11; final version accepted December 6.
Published online: June 2013
Published in print: June 2013