研究单位：[1]Stryker Neurovascular[2]University of California, San Francisco, CA[3]Barrow Neurological Institute, Phoenix, AZ[4]Newcastle Upon Tyne Hospitals, NHS Trust, UK[5]St. Joseph's Hospital Barrow Neurological Institute,Phoenix, Arizona, United States, 85013[6]Tucson Medical Center,Tucson, Arizona, United States, 85712[7]Yale-New Haven Hospital,New Haven, Connecticut, United States, 06510[8]Rush Presbyterian,Chicago, Illinois, United States, 60640[9]The Universtiy of Iowa,Iowa City, Iowa, United States, 52242[10]University of Maryland,Baltimore, Maryland, United States, 21201[11]Massachusetts General Hospital,Boston, Massachusetts, United States, 02114[12]University of Massachusetts Worcester,Worcester, Massachusetts, United States, 01655[13]Providence Detroit,Southfield, Michigan, United States, 48075[14]St. Joseph's Hospital,St. Paul, Minnesota, United States, 55104[15]Saint Luke's Hospital of Kansas City,Kansas City, Missouri, United States, 64111[16]Barnes Jewish Mallinckrodt Institute of Radiology,St. Louis, Missouri, United States, 63110[17]Sunrise Hospital and Medical Center,Las Vegas, Nevada, United States, 89109[18]University of New Mexico Department of Neurosurgery,Albuquerque, New Mexico, United States, 87131[19]Stony Brook Medical Center,Stony Brook, New York, United States, 11794[20]Carolina Neurosurgery & Spine Associates, PA,Charlotte, North Carolina, United States, 28207[21]Cleveland Clinic Foundation,Cleveland, Ohio, United States, 44195[22]Mercy Health Center,Oklahoma City, Oklahoma, United States, 73120[23]OHSU,Portland, Oregon, United States, 97239[24]Medical University of South Carolina,Charleston, South Carolina, United States, 29425[25]Fort Sanders Regional Medical Center,Knoxville, Tennessee, United States, 37916[26]University of Texas Southwestern Medical Center,Dallas, Texas, United States, 75390-8896[27]Methodist Hospital,Houston, Texas, United States, 77030[28]University of Washington Harborview Medical Center,Seattle, Washington, United States, 98104[29]Sacred Heart Providence,Spokane, Washington, United States, 99204[30]University of Wisconsin Hospital and Center,Madison, Wisconsin, United States, 53792[31]Royal Melbourne Hospital,Parkville, Australia, 3052[32]Montreal Neurological Institute and Hospital,Montreal, Quebec, Canada, H3A 2B4[33]Xuan Wu Hospital,Beijing, China[34]CHU Montpelier,Montpellier, France, 34295[35]Klinikum Augsburg,Augsburg, Germany, 86156[36]Universitaetsklinikum Freiburg,Freiburg, Germany, 79106[37]Asklepios Klinik Altona,Hamburg, Germany, 22763[38]Universitaetsklinikum des Saarlandes,Homburg/Saar, Germany, 66421[39]Instituto Nacional de Neurologia e Neurocirurgia,Mexico City, Mexico, 14269[40]Rikshospitalet University Hospital,Oslo, Norway, 0027[41]Hospital General,Alicante, Spain[42]Hospital Clinico Y provincial,Barcelona, Spain[43]Clinica Ntra Sra Del Rosario Hospital Ruber Internacional,Madrid, Spain, 28056[44]Hospital Donostia,San Sebastian, Spain[45]Istanbul University Cerrahpaşa Tıp Fakültesi,Kocamustafapasa, Istanbul, Turkey, 34300[46]The Walton Centre,Fazakerley, Liverpool, United Kingdom, L9 7LJ[47]Newcastle General Hospital Department of Neuroradiology,Tyne and Wear, United Kingdom, NE4 6BE
Primary Objectives:
To establish Target Aneurysm Recurrence (TAR) rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms. TAR is defined as clinically relevant recurrence resulting in: target aneurysm reintervention, rupture/re-rupture and/or death from an unknown cause.
To correlate defined angiographic endpoints with TAR rates and assess their predictive value, thereby providing a framework to establish clinically relevant endpoints for future studies.
Secondary Objectives:
To evaluate device characteristics, incidence and severity of device-related adverse events, including death, neurological deterioration and changes in functional abilities.
To establish angiographic recurrence rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms.
To explore an experimental, quantitative and volumetric endpoint and correlate these with existing qualitative assessments.
