Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial "CREST-2"

Recruiting

Phase N/A Results N/A

Trial Description

Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.

Detailed Description

Prevention of stroke involves managing and treating risk factors. Most strokes are caused when blood flow to a portion of the brain is blocked. One place this often happens is in the carotid artery. This blockage is called atherosclerosis or hardening of the arteries.
The purpose of this trial is to determine the best way to prevent strokes in people who have a high amount of blockage of their carotid artery but no stroke symptoms related to that blockage. Each eligible participant will be evaluated to determine which procedure(s) is best for him/her. All participants will receive intensive medical treatment. In addition, participants will be randomized to receive the selected procedure or not.
The trial will be conducted in the United States and Canada by physicians carefully selected on their ability to perform the procedures at low risk. Another key component of the trial is that important stroke risk factors, including hypertension, diabetes, high cholesterol, cigarette smoking, physical activity, and diet will be managed intensively. Participants will remain in the study for 4 years.

Conditions

Interventions

  • Carotid Endarterectomy Procedure
    ARM 1: Kind: Experimental
    Label: Carotid Endarterectomy (CEA)
    Description: Carotid endarterectomy
  • Carotid Endarterectomy (CEA) Procedure
    Intervention Desc: Carotid endarterectomy
    ARM 1: Kind: Experimental
    Label: Carotid Endarterectomy (CEA)
    Description: Carotid Endarterectomy
  • Carotid stenting Device
    ARM 1: Kind: Experimental
    Label: Carotid Stenting (CAS)
    Description: Carotid stenting
  • Carotid Stenting (CAS) Device
    Intervention Desc: Carotid stenting
    ARM 1: Kind: Experimental
    Label: Carotid Stenting (CAS)
    Description: Carotid Stenting
  • Intensive Medical Management - no CEA Other
    Intervention Desc: Intensive Medical Management alone - no CEA
    ARM 1: Kind: Experimental
    Label: Intensive Medical Management - no CEA
    Description: Intensive Medical Management alone - no CEA
  • Intensive Medical Management - no CAS Other
    Intervention Desc: Intensive Medical Management alone - no CAS
    ARM 1: Kind: Experimental
    Label: Intensive Medical Management - no CAS
    Description: Intensive Medical Management alone - no CAS

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Stroke and death 4 years No
Secondary Cognitive Function 4 years No
Secondary Major Stroke 4 years No
Secondary Effect modification 4 years No

Sponsors