Study Summary
This trial will compare two methods of preventing stroke in patients with asymptomatic high-grade carotid stenosis. One group will have endarterectomy and the other will have carotid stenting with embolic protection.
Eligible Conditions
- Carotid Stenosis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 4 years
4 years
Cognitive Function
Effect modification
Major Stroke
Stroke and death
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Carotid Endarterectomy (CEA)
1 of 4
Carotid Stenting (CAS)
1 of 4
Intensive Medical Management - no CAS
1 of 4
Intensive Medical Management - no CEA
1 of 4
Active Control
Experimental Treatment
2480 Total Participants · 4 Treatment Groups
Primary Treatment: Intensive Medical Management - no CAS · No Placebo Group · N/A
Intensive Medical Management - no CAS
Other
Experimental Group · 1 Intervention: Intensive Medical Management - no CAS · Intervention Types: OtherIntensive Medical Management - no CEA
Other
Experimental Group · 1 Intervention: Intensive Medical Management - no CEA · Intervention Types: OtherCarotid Endarterectomy (CEA)
Procedure
ActiveComparator Group · 1 Intervention: Carotid endarterectomy (CEA) · Intervention Types: ProcedureCarotid Stenting (CAS)
Device
ActiveComparator Group · 1 Intervention: Carotid Stenting (CAS) · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,260 Previous Clinical Trials
452,045 Total Patients Enrolled
4 Trials studying Carotid Stenosis
4,602 Patients Enrolled for Carotid Stenosis
Thomas G. Brott, M.D.Lead Sponsor
James F. Meschia, MDPrincipal InvestigatorMayo Clinic
Thomas G. Brott, MD5.01 ReviewsPrincipal Investigator - Mayo Clinic
Mayo Clinic
Brajesh K. Lal, MDPrincipal InvestigatorUniversity of Maryland
1 Previous Clinical Trials
800 Total Patients Enrolled
George Howard, DrPHPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
1,800 Total Patients Enrolled
Eligibility Criteria
Age 35 - 100 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have no medical history of stroke or transient ischemic attack and negative responses to all of the symptom items on the Questionnaire for Verifying Stroke-free Status (QVSS).
You are 35 years old or older.\n
You must agree to comply with all protocol-specified follow-up appointments.
Patients must sign a consent form that has been approved by the local governing IRB/MEC of the respective clinical site.
You have carotid stenosis
Who else is applying?
What state do they live in?
| West Virginia | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| West Virginia University | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
References
- Lazar, Ronald M., Virginia G. Wadley, Terina Myers, Michael R. Jones, Donald V. Heck, Wayne M. Clark, Randolph S. Marshall, et al.. 2021. “Baseline Cognitive Impairment in Patients with Asymptomatic Carotid Stenosis in the CREST-2 Trial”. Stroke. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/strokeaha.120.032972.
- Haley, William, Fayaz Shawl, W. Charles Sternbergh III, Tanya N. Turan, Kevin Barrett, Jenifer Voeks, Thomas Brott, and James F. Meschia. 2021. “Non-adherence to Antihypertensive Guidelines in Patients with Asymptomatic Carotid Stenosis”. Journal of Stroke and Cerebrovascular Diseases. Elsevier BV. doi:10.1016/j.jstrokecerebrovasdis.2021.105918.
- Turan, Tanya N., James F. Meschia, Marc I. Chimowitz, Ana Roldan, Todd LeMatty, Sothear Luke, Linda Breathitt, Robin Eiland, Jon Foley, and Thomas G. Brott. 2020. “Mitigating the Effects of COVID-19 Pandemic on Controlling Vascular Risk Factors Among Participants in a Carotid Stenosis Trial”. Journal of Stroke and Cerebrovascular Diseases. Elsevier BV. doi:10.1016/j.jstrokecerebrovasdis.2020.105362.
- Turan, Tanya N., Jenifer H. Voeks, Marc I. Chimowitz, Ana Roldan, Todd LeMatty, William Haley, Maria Lopes-Virella, et al.. 2020. “Rationale, Design, and Implementation of Intensive Risk Factor Treatment in the CREST2 Trial”. Stroke. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/strokeaha.120.030730.
- Lal, Brajesh K., James F. Meschia, Gary S. Roubin, Brian Jankowitz, Donald Heck, Tudor Jovin, Christopher J. White, et al.. 2020. “Factors Influencing Credentialing of Interventionists in the CREST-2 Trial”. Journal of Vascular Surgery. Elsevier BV. doi:10.1016/j.jvs.2019.05.035.
- Musiałek, Piotr, and Gary S. Roubin. 2019. “Commentary: Double-layer Carotid Stents: From the Clinical Need, Through a Stent-in-stent Strategy, to Effective Plaque Isolation… the Journey Toward Safe Carotid Revascularization Using the Endovascular Route”. Journal of Endovascular Therapy. SAGE Publications. doi:10.1177/1526602819861546.
- Lal, Brajesh K., James F. Meschia, and Thomas G. Brott. 2017. “Clinical Need, Design, and Goals for the Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial”. Seminars in Vascular Surgery. Elsevier BV. doi:10.1053/j.semvascsurg.2017.04.004.
- Demaerschalk, Bart M., Robert D. Brown Jr, Gary S. Roubin, Virginia J. Howard, Eldina Cesko, Kevin M. Barrett, Mary E. Longbottom, et al.. 2017. “Factors Associated with Time to Site Activation, Randomization, and Enrollment Performance in a Stroke Prevention Trial”. Stroke. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/strokeaha.117.016976.
- Howard, Virginia J, James F Meschia, Brajesh K Lal, Tanya N Turan, Gary S Roubin, Robert D Brown Jr, Jenifer H Voeks, et al.. 2017. “Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis: Protocol of the CREST-2 Clinical Trials”. International Journal of Stroke. SAGE Publications. doi:10.1177/1747493017706238.
- Musiałek, Piotr, and Gary S. Roubin. 2019. “Commentary: Double-layer Carotid Stents: From the Clinical Need, Through a Stent-in-stent Strategy, to Effective Plaque Isolation… the Journey Toward Safe Carotid Revascularization Using the Endovascular Route”. Journal of Endovascular Therapy. SAGE Publications. doi:10.1177/1526602819861546.
- Lazar, Ronald M., Virginia G. Wadley, Terina Myers, Michael R. Jones, Donald V. Heck, Wayne M. Clark, Randolph S. Marshall, et al.. 2021. “Baseline Cognitive Impairment in Patients with Asymptomatic Carotid Stenosis in the CREST-2 Trial”. Stroke. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/strokeaha.120.032972.
- Kamtchum-Tatuene J, Saba L, Heldner MR, Poorthuis MHF, de Borst GJ, Rundek T, Kakkos SK, Chaturvedi S, Topakian R, Polak JF, Jickling GC; Carotid Atherosclerosis and Stroke Collaboration (CASCO). Interleukin-6 Predicts Carotid Plaque Severity, Vulnerability, and Progression. Circ Res. 2022 Jul 8;131(2):e22-e33. doi: 10.1161/CIRCRESAHA.122.320877. Epub 2022 Jun 17.
- Musialek P, Roubin GS. Commentary: Double-Layer Carotid Stents: From the Clinical Need, through a Stent-in-Stent Strategy, to Effective Plaque Isolation... the Journey Toward Safe Carotid Revascularization Using the Endovascular Route. J Endovasc Ther. 2019 Aug;26(4):572-577. doi: 10.1177/1526602819861546. No abstract available.
- Thomas G. Brott, M.D. 2014. "Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02089217.
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