Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (NCT02089217) | Clinical Trial Compass
CompletedNot Applicable
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
United States2,486 participantsStarted 2014-12-09
Plain-language summary
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.
Who can participate
Age range35 Years – 100 Years
SexALL
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Inclusion criteria
✓. Patients ≥35 years old.
✓. Carotid stenosis defined as:
✓. an end diastolic velocity ≥100 cm/s, or
✓. internal carotid/common carotid artery peak systolic velocity ratio ≥4.0, or
✓. computed tomography angiography (CTA) with ≥ 70% stenosis, or
✓. magnetic resonance angiography (MRA) with ≥ 70% stenosis.
✓. No medical history of stroke or transient ischemic attack (TIA) ipsilateral to the stenosis within 180 days of randomization. Life-long asymptomatic patients will be defined as having 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).
✓. Patients must have a modified Rankin Scale (mRS) score of 0 or 1 at the time of informed consent.
Exclusion criteria
✕. Intolerance or allergic reaction to a study medication without a suitable management alternative.
✕. GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy.
✕. Prior major ipsilateral stroke in the past with substantial residual disability (mRS ≥ 2) that is likely to confound study outcomes.
✕. Severe dementia.
✕. History of major symptomatic intracranial hemorrhage within 12 months that was not related to anticoagulation.
✕. Prior Intracranial hemorrhage that the investigator believes represents a contraindication to the perioperative or periprocedural antithrombotic and antiplatelet treatments necessary to complete endarterectomy or stenting per protocol.
✕. Current neurologic illness characterized by fleeting or fixed neurologic deficits that cannot be distinguished from TIA or stroke.
✕. Patient objects to future blood transfusions.