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

TLDR

The study evaluates the safety and effectiveness of the Pipeline Embolization Device in treating complex, uncoilable or failed internal carotid artery aneurysms in a multicenter prospective trial. The trial enrolled 108 patients with large or giant wide‑necked aneurysms, obtained IRB approval and informed consent, and assessed safety and effectiveness at 180 days using angiographic occlusion and major stroke or neurologic death endpoints, with technical success in 107 of 108 cases. The device achieved complete occlusion in 73.6% of aneurysms and a 5.6% rate of major ipsilateral stroke or neurologic death, demonstrating reasonable safety and effectiveness for large or giant internal carotid artery aneurysms.

Abstract

To evaluate the safety and effectiveness of the Pipeline Embolization Device (PED; ev3/Covidien, Irvine, Calif) in the treatment of complex intracranial aneurysms.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.