Intensive Medical Management - no CAS for Carotid Stenosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Carotid StenosisIntensive Medical Management - no CAS - Other
Eligibility
35 - 100
All Sexes
What conditions do you have?
Select

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

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 4 years

4 years
Cognitive Function
Effect modification
Major Stroke
Stroke and death

Trial Safety

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: Other
Intensive Medical Management - no CEA
Other
Experimental Group · 1 Intervention: Intensive Medical Management - no CEA · Intervention Types: Other
Carotid Endarterectomy (CEA)
Procedure
ActiveComparator Group · 1 Intervention: Carotid endarterectomy (CEA) · Intervention Types: Procedure
Carotid Stenting (CAS)
Device
ActiveComparator Group · 1 Intervention: Carotid Stenting (CAS) · Intervention Types: Device

Trial 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 Virginia100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
West Virginia University100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References