Endovascular Revascularization for Chronic Carotid Artery Occlusion Trial

Exclusion Criteria44

• Patient has acute stroke within 90 days,
• Intolerance or allergic reaction to a study medication without a suitable management alternative.
• Patient is expected to have the ADP antagonist therapy interruption within 3 months after the procedure.
• GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy
• Bleeding diathesis
• Intracranial hemorrhage within the past 12 months.
• Platelet count <100,000/μl or history of heparin-induced thrombocytopenia.
• Other high-risk cardiac sources of emboli, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area < 1.0 cm2), endocarditis, moderate to severe mitral stenosis, left atrial thrombus, or any intracardiac mass, or known unrepaired patent foramen ovale (PFO) with prior paradoxical embolism.
• Any major surgery, major trauma, revascularization procedure within the past 1 month.
• Acute coronary syndrome within the past 1 month or acute coronary syndrome (ACS) that is not amenable to revascularization (patients should undergo planned coronary revascularization at least 30 days before randomization).
• Inability to understand and cooperate with study procedures or provide informed consent.
• Patients with < 5 years life expectancy
• Concomitant vascular conditions precluding endovascular revascularization procedure;
• Previous ipsilateral carotid artery stenting
• Intracranial aneurysm or arteriovenous malformation;
• Educational level lower than elementary school;
• Aphasia or right-sided hemiparesis
• Marked depression.
• Severe dementia.
• Part 2: Randomized control study
• Patient has acute stroke within 90 days,
• Prior major ipsilateral stroke in the past with moderate disability (mRS ≥ 3) that is likely to confound study outcomes.
• Current neurologic illness characterized by fleeting or fixed neurologic deficits that cannot be distinguished from TIA or stroke.
• Patient has significant renal insufficiency with estimated glomerular filtration rate (eGFR) <30 ml/min (at screening). and would not receive renal replacement therapy if contrast agent related nephropathy occurs
• Intolerance or allergic reaction to a study medication without a suitable management alternative.
• Patient is expected to have the ADP antagonist therapy interruption within 3 months after the procedure.
• GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy
• Bleeding diathesis
• Intracranial hemorrhage within the past 12 months.
• Platelet count <100,000/μl or history of heparin-induced thrombocytopenia.
• Other high-risk cardiac sources of emboli, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area < 1.0 cm2), endocarditis, moderate to severe mitral stenosis, left atrial thrombus, or any intracardiac mass, or known unrepaired PFO with prior paradoxical embolism.
• Major (non-carotid) surgery/procedures planned within 3 months after enrollment.
• Any major surgery, major trauma, revascularization procedure within the past 1 month.
• Acute coronary syndrome within the past 1 month or ACS that is not amenable to revascularization (patients should undergo planned coronary revascularization at least 30 days before randomization).
• Coronary artery disease with two or more proximal or major diseased coronary arteries with ≥ 70% stenosis that have not, or cannot, be revascularized.
• Inability to understand and cooperate with study procedures or provide informed consent.
• Patients with < 5 years life expectancy
• Concomitant vascular conditions precluding endovascular revascularization procedure;
• Previous ipsilateral carotid artery stenting
• Intracranial aneurysm or arteriovenous malformation;
• Educational level lower than elementary school;
• Aphasia or right-sided hemiparesis
• Marked depression.
• Severe dementia.