Open AccessStudy Design of the CLOSURE I Trial
Author(s) -
Anthony J. Furlan,
Mark Reisman,
Joseph M. Massaro,
Laura Mauri,
Harold P. Adams,
Gregory W. Albers,
Robert A. Felberg,
Howard C. Herrmann,
Saibal Kar,
Michael J. Landzberg,
Albert E. Raizner,
Lawrence R. Wechsler
Publication year - 2010
Publication title -
stroke
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.397
H-Index - 319
eISSN - 1524-4628
pISSN - 0039-2499
DOI - 10.1161/strokeaha.110.593376
Subject(s) - medicine , patent foramen ovale , randomized controlled trial , stroke (engine) , paradoxical embolism , etiology , surgery , clinical trial , embolism , percutaneous , mechanical engineering , engineering
Some strokes of unknown etiology may be the result of a paradoxical embolism traversing through a nonfused foramen ovale (patent foramen ovale [PFO]). The utility of percutaneously placed devices for treatment of patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO is unknown. In addition, there are no clear data about the utility of medical interventions or other surgical procedures in this situation. Despite limited data, many patients are being treated with PFO closure devices. Thus, there is a strong need for clinical trials that test the potential efficacy of PFO occlusive devices in this situation. To address this gap in medical knowledge, we designed the CLOSURE I trial, a randomized, clinical trial comparing the use of a percutaneously placed PFO occlusive device and best medical therapy versus best medical therapy alone for prevention of recurrent ischemic neurologic symptoms among persons with TIA or ischemic stroke.