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Standardized definitions and clinical endpoints in carotid artery and supra‐aortic trunk revascularization trials
Author(s) -
Nedeltchev Krassen,
Pattynama Peter M.,
Biaminoo Giancarlo,
Diehm Nicolas,
Jaff Michael R.,
Hopkins L. Nelson,
Ramee Stephen,
van Sambeek Marc,
Talen Aly,
Vermassen Frank,
Cremonesi Alberto
Publication year - 2010
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.22560
Subject(s) - medicine , revascularization , clinical trial , food and drug administration , multidisciplinary approach , stroke (engine) , carotid arteries , medline , disease , intensive care medicine , medical physics , surgery , medical emergency , mechanical engineering , social science , sociology , myocardial infarction , law , political science , engineering
Background: Endovascular therapy has emerged as a promising alternative to open surgery for stroke prevention in patients with obstructive disease of the supra‐aortic arteries. Although most previous studies have used similar safety and efficacy endpoints, differences in definitions, timing of assessments, and standards of reporting have hampered direct comparisons across various trials. Methods and results: The DEFINE group, an informal collaboration of multidisciplinary physicians, involved in the therapy of patients with obstructive disease of the supra‐aortic arteries in Europe and the United States reviewed the current literature and, after extensive correspondence and meetings, proposed the definitions outlined in the present manuscript. Three meetings including all authors of the manuscript, along with representatives of the United States Food and Drug Administration (FDA) and commercial device manufacturers were held in Barcelona, Spain, in May 2008, in Munich, Germany, in July 2008, and in New York in November 2008. The proposed definitions encompass baseline clinical and anatomic characteristics, clinical and radiologic outcomes, complications, standards of reporting, and timing of assessment. Conclusions: Considering the broad consensus between the multidisciplinary scientific members and the regulatory authorities, the proposed definitions are expected to find adoption in future clinical investigations. These definitions can be applied to both endovascular and open surgery trials and will allow reliable comparisons between these two revascularization methods. © 2010 Wiley‐Liss, Inc.