Rationale and design of a multidisciplinary national real-world registry on carotid stenting: the Italian Registry for Carotid Stenting (RISC).
The Registro Italiano per lo Stenting Carotideo (RISC, Italian Registry for Carotid Stenting) has been organized by Italian specialists from different disciplines directly involved in the prevention of stroke due to carotid plaques through stenting of carotid lesions. The Registry has been endorsed by the national societies of 4 different specialties: vascular surgery, interventional cardiology, radiology, and neuroradiology. Each society contributed in the planning stage. The basis for the registry is to collect data on carotid stenting procedures performed by different specialists with different techniques in a "real-world" setting without the limitations of a randomized clinical trial. The Registry was funded to enroll at least 1200 patients over a minimum period of 36 months. The results will be analyzed using the intention-to-treat principle and are anticipated in late 2006. Primary endpoints of the registry are the 30-day combined death and stroke rate and the occurrence of restenosis and ipsilateral neurological deficit at 12 and 24 months. Considerable attention has been paid to the registry's quality control program to ensure scientific validation. An online database facilitates the collection of data with speed and accuracy.
Biasi
Giorgio M
GM
Department of Surgical Sciences and Intensive Care, University of Milano-Bicocca, Vascular Surgery Unit, San Gerardo Hospital, Monza, Italy. giorgio.biasi@unimib.it
Deleo
Gaetano
G
Froio
Alberto
A
Cremonesi
Alberto
A
Inglese
Luigi
L
Lavitrano
Marialuisa
M
Setacci
Carlo
C
D016893:Carotid Stenosis / Q000401:mortality / Q000601:surgery*; D006801:Humans; D007558:Italy / Q000453:epidemiology; D011786:Quality Control; D012008:Recurrence; D012042:Registries; D012107:Research Design; D015607:Stents; D014584:User-Computer Interface