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Review
. 2023 May 30;100(22):1060-1066.
doi: 10.1212/WNL.0000000000207075. Epub 2023 Feb 6.

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

James F Meschia  1 , Brajesh Lal  2 , Gary Roubin  2 , Tanya N Turan  2 , Virginia J Howard  2 , Richard T Benson  2 , Kaley Carman  2 , George Howard  2 , Thomas G Brott  2
Affiliations
Review

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

James F Meschia et al. Neurology. .

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. In this study, 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. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov number: NCT02089217.

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Conflict of interest statement

J.F. Meschia receives National Institute for Neurological Disorders and Stroke (NINDS) grant support for efforts on the CREST-2 trial. B.K. Lal receives NINDS grant support for efforts on the CREST-2 trial. G.S. Roubin receives NINDS grant support for efforts on the CREST-2 trial. In addition, he has equity holdings in Contego Medical Inc., Inspire MD Inc., Excision Medical Inc., and CardioMech Inc. T.N. Turan receives NINDS grant support for efforts on the CREST-2 trial. V.J. Howard receives NINDS grant support for efforts on the CREST-2 trial. R.T. Benson reports no disclosures relevant to the manuscript. K. Carman receives NINDS grant support for efforts on the CREST-2 trial. G. Howard receives NINDS grant support for efforts on the CREST-2 trial. T.G. Brott receives NINDS grant support for efforts on the CREST-2 trial. Go to Neurology.org/N for full disclosures.

Figures

Figure 1
Figure 1. Monthly Mean SBP of All Enrolled Participants at Baseline and Last Follow-up From Enrollment to May 2022
Dashed line indicates time from protocol change. Instability in trends early on is attributable to small numbers. SBP = systolic blood pressure.
Figure 2
Figure 2. Monthly Mean LDL of All Enrolled Participants at Baseline and Last Follow-up From Enrollment to May 2022
Dashed line indicates time of protocol change. Instability in trends early on is attributable to small numbers. LDL = low-density lipoprotein.
See this image and copyright information in PMC

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