Carotid Occlusion Clinical Trial
— ERCAOOfficial title:
Endovascular Revascularization for Chronic Carotid Artery Occlusion Trial (ERCAO Trial) Part 1: Prospective Clinical Registry Study Part 2: Prospective Randomized Control Trial Study
NCT number | NCT03179774 |
Other study ID # | 201702049RINA |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 17, 2017 |
Est. completion date | April 2025 |
Revascularization for carotid artery occlusion (CAO) remained controversial, there is no prospective randomized control trial (RCT) regarding carotid artery stenting (CAS) in CAO patients. The investigators conduct a prospective study composed of clinical registry arm and RCT arm. The main purpose of the study is investigate neurocognitive function at 3 months and thereafter up to 12 months.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | April 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Part 1: Clinical registry study Inclusion criteria for clinical registry study - Patient age 20 years or older - Abnormal cerebral perfusion by CTP or MRI - No medical history of stroke or transient ischemic attack (TIA) ipsilateral to the carotid occlusion within 90 days of randomization - Women must not be of childbearing potential or, if of childbearing potential, have a negative pregnancy test prior to randomization. Exclusion Criteria for clinical registry study - 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 Inclusion Criteria for randomized control study - Patient age 20 years or older - Abnormal cerebral perfusion by CTP or MRI - No medical history of stroke or TIA ipsilateral to the carotid occlusion within 90 days of randomization - Patients must have a modified Rankin Scale (mRS) =2 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. - Randomization will apply to only 1 carotid artery occlusion for patients with bilateral carotid occlusion. Intervention of the contralateral stenosis, should it exists, may be done in according to clinical indications at least 30 days prior to randomization. Exclusion Criteria 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Major procedure complication | Major procedure complication includes intracranial hemorrhage, myocardial infarction, embolic stroke, vascular complication and death during endovascular revascularization or within 30 days after endovascular revascularization. | 30 days | |
Other | Bleeding complication | any bleeding events during the study | one year | |
Primary | NCF improvement by Alzheimer Disease Assessment Scale-Cognitive subscale (ADAS-Cog) | Neurocognitive function was evaluated by ADAS-Cog | at 3 months and thereafter up to 12 months | |
Primary | NCF improvement by Mini-Mental State Examination (MMSE) | Neurocognitive function was evaluated by MMSE. | at 3 months and thereafter up to 12 months | |
Primary | NCF improvement by verbal fluency test | Neurocognitive function was evaluated verbal fluency test | at 3 months and thereafter up to 12 months | |
Primary | NCF improvement by verbal fluency test Color Trails Test Parts 1 | Neurocognitive function was evaluated by Color Trails Test Parts 1 | at 3 months and thereafter up to 12 months | |
Primary | NCF improvement by verbal fluency test Color Trails Test Parts 2 | Neurocognitive function was evaluated by Color Trails Test Parts 2 | at 3 months and thereafter up to 12 months | |
Secondary | Death and stroke | Cumulative incidence of death and ipsilateral stroke | within 30 days after the procedure and between 31 days and 1 year | |
Secondary | Major stroke, ischemic stroke, or hemorrhagic stroke | Cumulative incidence of major stroke, ischemic stroke, or hemorrhagic stroke | within 30 days after the procedure and between 31 days and 1 year | |
Secondary | Cambridge Neuropsychological Test Automated Battery (CANTAB) | The CANTAB is a computerized test battery for cognitive function evaluation which has been validated and widely used worldwide. CANTAB tests are simple to administer and show strong correlations to brain constructs and known deficits in various disorders, as well as high sensitivity to interventions and small changes over time. It is designed to be administered by trained psychologists with standardized procedures. Tasks of the CANTAB involving practice and attention, memory, executive function and decision making would be administered to all the participants in this study. | at 3 months and thereafter up to 12 months | |
Secondary | Change of cerebral perfusion | Change of cerebral perfusion measured by CT perfusion | at 3 months and thereafter up to 12 months | |
Secondary | Target vessel revascularization rate | Target vessel revascularization rate | one year | |
Secondary | Technique success rate | Technique success is defined if the occlusion segment was recanalized with final residual diameter stenosis of <20%, and establishing grade 3 antegrade Thrombolysis in Cerebral Infarction (TICI) flow. | 30 days | |
Secondary | Procedure success rate | Procedure success: the occlusion segment was stented with final residual diameter stenosis of <20%, and establishing grade 3 antegrade TICI flow and without periprocedural complications. | 30 days |
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