Background Preliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications. Objective To evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms. Methods PREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death. Results A total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured <7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1±0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study's primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140). Conclusions Treatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications. Trial registration NCT02186561.
|Number of pages||5|
|Journal||Journal of NeuroInterventional Surgery|
|State||Published - Jan 1 2020|
Bibliographical noteFunding Information:
Competing interests rh serves as a consultant for Medtronic, stryker, codman, and Microvention and is a stock holder of in neuroco. DFK is president of Marblehead Medical and has patent pending in balloon catheter technologies. he has received research support from Medtronic, MicroVention, neurosave, neurogami, sequent Medical, neurosigma, and insera, and also serves on the scientific advisory Board for Triticum and Boston scientific. PKn is a consultant for Medtronic. as is a modest consultant for amnis Therapeutics, Boston scientific, canon Medical systems Usa, cerebrotech Medical systems, claret Medical, corindus, endostream Medical, guidepoint global consulting, imperative care, integra, rapid Medical, rebound Therapeutics corp, silk road Medical, stimMed, stryker, Three rivers Medical, Vassol, and Wl gore and associates. he is also a consultant and serves on the national Pi/steering committee for cerenovus, Medtronic, MicroVention, and Penumbra. he serves on the national Pi/steering committee for the POsiTiVe Trial for the Medical University of south carolina and as DsMB chair for the heaT Trial for northwest University and has ownership interest in amnis Therapeutics, apama Medical, BlinkTBi, Buffalo Technology Partners, cardinal health, cerebrotech Medical systems, claret Medical, cognition Medical, endostream Medical ltd, imperative care, international Medical Distribution Partners, rebound Therapeutics corp, silk road Medical, stimMed, synchron, Three rivers Medical, and Viseon. PJ serves as a consultant for Medtronic. VMP serves as a consultant/steering committee member for stryker, Penumbra, and Balt, and as a consultant for Medtronic and neurovasc, and receives a research grant from Philips. sZ serves as a scientific consultant regarding trial design and conduct to Medtronic. gPc serves as a consultant for Medtronic, Microvention-Terumo, and stryker. MM serves as a consultant for cerebrotech, imperative care, and Penumbra. cs has received honoraria from the american association of neurological surgeons and Toshiba, and has ownership interest in nTi. Frh serves on the speakers’ Bureau for Medtronic and as a consultant for Penumbra and cordis neurovascular (Johnson & Johnson). cg serves as a consultant, proctor, and on the speakers’ Bureau for Medtronic and stryker, and is on the speaker’s Bureau for genentech. PT serves as a consultant for covidien. gT serves as a consultant for Dynamed eBscO. JFF is an equity interest holder for Fawkes Biotechnology, llc, and is a consultant for stream Biomedical and for Medtronic. Mc is a consultant for Medtronic, stryker, Penumbra, genentech, and ge. PK is a consultant for stryker neurovascular, Medtronic, and cerenovus. DFi is a consultant and has received research support from Microvention/Terumo. DFr is a consultant and on the speakers’ Bureau for Penumbra, stryker neurovascular, genentech, MicroVention, and codman. OD serves as a proctor for Microvention/ Terumo. aMM is a cofounder, investor, and shareholder of cereVasc. asP consults for and has received research grants from Medtronic neurovascular and stryker neurovascular.
The PreMier study was supported by Medtronic, inc.
© Author(s) (or their employer(s)) 2020.
- flow diverter
ASJC Scopus subject areas
- Clinical Neurology