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February 06, 2023Contemporary Issues in Practice, Education, & Research

Adapting to Evolving Technologies and Treatment Guidelines in a Procedural Trial: A Qualitative Review of the CREST-2 Experience

View ORCID ProfileJames F Meschia, View ORCID ProfileBrajesh Lal, View ORCID ProfileGary Roubin, Tanya N. Turan, View ORCID ProfileVirginia J. Howard, View ORCID ProfileRichard T. Benson, View ORCID ProfileKaley Carman, George Howard, View ORCID ProfileThomas G. Brott
First published February 6, 2023, DOI: https://doi.org/10.1212/WNL.0000000000207075
James F Meschia
1Mayo Clinic, Jacksonville, Florida
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  • For correspondence: meschia.james@mayo.edu
Brajesh Lal
2University of Maryland School of Medicine, Baltimore. Maryland
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Gary Roubin
3CREST-2 Executive Committee; Jackson, Wyoming
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Tanya N. Turan
4Medical University of South Carolina, Charleston, South Carolina
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Virginia J. Howard
5University of Alabama at Birmingham, Birmingham, Alabama
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Richard T. Benson
6National Institute of Neurological Disorders and Stroke, Bethesda, Maryland
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Kaley Carman
1Mayo Clinic, Jacksonville, Florida
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George Howard
5University of Alabama at Birmingham, Birmingham, Alabama
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Thomas G. Brott
1Mayo Clinic, Jacksonville, Florida
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Citation
Adapting to Evolving Technologies and Treatment Guidelines in a Procedural Trial: A Qualitative Review of the CREST-2 Experience
James F Meschia, Brajesh Lal, Gary Roubin, Tanya N. Turan, Virginia J. Howard, Richard T. Benson, Kaley Carman, George Howard, Thomas G. Brott
Neurology Feb 2023, 10.1212/WNL.0000000000207075; DOI: 10.1212/WNL.0000000000207075

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Abstract

Multiple challenges confront procedural trials, including slow enrollment, lack of equipoise among patients and physicians, and failure to achieve adequate masking. Nonetheless, randomized clinical trials provide the best evidence of efficacy. The evolution of technology, techniques, and standards of care during the conduct of procedural trials challenges external validity. Herein, we review how a multicenter trial of revascularization of asymptomatic carotid arteries for stroke prevention has managed changes in treating carotid stenosis and medical management of atherothrombotic disease.

  • Received September 27, 2022.
  • Accepted in final form January 4, 2023.
  • Written work prepared by employees of the Federal Government as part of their official duties is, under the U.S. Copyright Act, a "work of the United States Government" for which copyright protection under Title 17 of the United States Code is not available. As such, copyright does not extend to the contributions of employees of the Federal Government.

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