Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Details
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.
Eligibility
You can join if...
General Inclusion Criteria:
Carotid stenosis defined as:
Stenosis greater than or equal to 70% by catheter angiography (NASCET Criteria); OR
by DUS with greater than or equal to 70% stenosis defined by a peak systolic velocity of at least 230 cm/s plus at least one of the following: an end diastolic velocity greater than or equal to 100 cm/s, or internal carotid/common carotid artery peak systolic velocity ratio greater than or equal to4.0, or CTA with greater than equal to 70% stenosis, or MRA with greater than or equal to 70% stenosis.
No medical history of stroke or 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).18
Patients must have a modified Rankin Scale score of 0 or 1 at the time of informed consent.
Women must not be of childbearing potential or, if of childbearing potential, have a negative pregnancy test prior to randomization.
Patients 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 Institutional Review Board (IRB)/Medical Ethics Committee (MEC) of the respective clinical site.
Randomization to treatment group will apply to only one carotid artery for patients with bilateral carotid stenosis. Management of the non-randomized stenosis may be done in accordance with local PI recommendation. Treatment of the non-study internal carotid artery must take place at least 30 days prior to randomization, or greater than 44 days after randomization and 30 days after the study procedure is completed (whichever is longer).
Carotid stenosis must be treatable with CEA, CAS, or either procedure.