Revascularization for Symptomatic Non-acute Carotid Artery Occlusion
Xuanwu Hospital, Beijing
1,000 participants
Jun 17, 2016
OBSERVATIONAL
Conditions
Summary
The short-term and long-term efficacy of recanalization therapy needs to be further confirmed by large-sample prospective studies. The comparison of success rate, complication rate and efficacy among the three recanalization modalities also needs to be further explored. The purpose of this cohort study is to observe the success rate, efficacy and safety of recanalization treatment for non-acute occlusion, and to further compare the advantages and disadvantages of CEA, endovascular intervention and hybrid surgery.
Eligibility
Inclusion Criteria8
- Older than 18 years old;
- Sign the informed consent form;
- Carotid occlusion at least 24h;
- Patients with clinical localization symptoms: ipsilateral hemisphere ischemia symptoms or ipsilateral eye ischemia symptoms or cognition impairment, with or without anterior circulation blood supply area infarction;
- DSA confirmed common carotid artery or internal carotid artery (mTICI=0) occlusion;
- Perfusion imaging confirms the presence of hypoperfusion in the corresponding area(CBF decrease);
- The optimal medical treatment for patients who still have ischemic symptoms;
- Routine DWI and ADC sequence examinations are performed before surgery no new infarction;
Exclusion Criteria16
- Intracranial arteriovenous malformation or aneurysm;
- Unstable angina, myocardial infarction (MI), or congestive heart failure in the last 6 months;
- Uncontrolled diabetes mellitus defined as glucose > 300 mg/dL (16.67 mmol/L);
- Patient is expected to have the ADP antagonist therapy interruption within 3 months after the procedure;
- Pregnant or in the perinatal period;
- Severe concomitant disease with poor prognosis (life expectancy < 3 years);
- Intolerance or allergies to any of the study medications, such as aspirin or clopidogrel;
- Allergy to iodine or radiographic contrast media;
- Concomitant vascular conditions precluding endovascular;
- Patients with large cerebral infarction within 2 weeks;
- History of ipsilateral vocal cord paralysis;
- Those with severe skin diseases who are expected to have difficulty healing the incision;
- Poor functional status before onset (mRS score 4-5 points).
- The area of infarction in the occluded vascular area exceeds half of the vascular supply area;
- Already have dementia or psychiatric illness and are unable to complete neurological and cognitive assessments.
- Any condition that in the surgeon's judgment suggests the patient an unsuitable surgical candidate.
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Interventions
Carotid endarterectomy (CEA) Surgeons follow the contemporary guideline combined with their experience and preference in order to ultimately select what is best suited for the patient and choose between CEA, CAS and Hybrid Sugery. Patients will receive 100 mg of aspirin or 75 mg of clopidogrel daily starting from at least 72 h prior to the CEA procedure and continued receiving the medication indefinitely. General anesthesia is recommended for CEA, although the use of standard or eversion endarterectomy, and a shunt or patch, is left to the discretion of the surgeon.
Carotid artery stenting (CAS) Surgeons follow the contemporary guideline combined with their experience and preference in order to ultimately select what is best suited for the patient and choose between CEA, CAS and Hybrid Sugery. Patients will be given 100 mg of aspirin plus 75 mg of clopidogrel daily for at least 3 days before the CAS procedure and for 90 days after the procedure. They will receive a daily dose of 100 mg aspirin or 75 mg clopidogrel thereafter. For the CAS procedure, general anesthesia and predilation prior to stent placement are recommended. Use of an embolic protection device is advised for all patients who undergo CAS.
Hybrid Surgery Surgeons follow the contemporary guideline combined with their experience and preference in order to ultimately select what is best suited for the patient and choose between CEA, CAS and Hybrid Sugery. Patients will be given 100 mg of aspirin plus 75 mg of clopidogrel daily for at least 5 days before the hybird surgery procedure. If they had stenting procedure, they will receive a daily dose of 100 mg aspirin and 75 mg clopidogrel thereafter. If not, they will take either 100mg aspirin or 75mg clopidogrel daily for life.
Locations(2)
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NCT06303414