Protocol NumberIDE G130221
There are two equally important primary hypotheses, which will be tested in two independent parallel, randomized clinical trials.
One trial will test the primary hypothesis that intensive medical management differs from the combination of CEA and intensive medical management in preventing the primary endpoint in patients with high-grade asymptomatic carotid stenosis.
One trial will test the primary hypothesis that intensive medical management differs from the combination of CAS and intensive medical management in preventing the primary endpoint in patients with high-grade asymptomatic carotid stenosis.
In both trials, the primary endpoint is stroke or death within 44 days after randomization or ipsilateral ischemic stroke thereafter at the 4-year time point of follow-up.
Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042
Dipankar Mukherjee, MD
- Patients ≥35 years old.
- Carotid stenosis defined as:
- Stenosis ≥70% by catheter angiography (NASCET Criteria); OR
- by DUS with ≥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 ≥100 cm/s, or
- internal carotid/common carotid artery peak systolic velocity ratio ≥4.0, or
- CTA with ≥ 70% stenosis, or
- MRA with ≥ 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.
- 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.