Clinical trials: past, present, and future.
Carotid stenting has been in evolution for the past 15 years. Initially limited by a lack of dedicated equipment, pivotal trials using both dedicated stent technology and embolic protection filters in patients at high risk for surgical endarterectomy have been largely completed, and results have compared favorably to both direct and historical surgical controls. While this has led to Food and Drug Administration approval of at least six carotid stent systems in the US, European randomized trials in standard surgical risk patients have had mixed results and confused the perception of the place of this technology in the care of patients with carotid stenosis. Current US trials are in progress, one nearing completion, and they will further contribute an understanding as to the place of stent therapy in the standard surgical risk patient, regardless of symptomatic status.
Gray
William A
WA
Cardiovascular Research Foundation, Columbia University Medical Center, New York, NY 10032, USA. wgray@crf.org
D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000266:history / Q000295:instrumentation* / Q000639:trends; D016893:Carotid Stenosis / Q000628:therapy*; D018795:Device Approval; D005060:Europe; D019317:Evidence-Based Medicine; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic / Q000266:history / Q000639:trends; D015607:Stents; D016896:Treatment Outcome; D014481:United States