Revascularization for Symptomatic Non-acute Carotid Artery Occlusion
ConditionNon-acute Carotid Artery Occlusion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorXuanwu Hospital, Beijing
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
People diagnosed with non-acute carotid occlusion, fulfilled the above eligible criteria in tertiary medical centers in China additionally will be enrolled consecutively.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Carotid Endarterectomy (CEA)
Procedure/SurgeryCarotid 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)
Procedure/SurgeryCarotid 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
Procedure/SurgeryHybrid 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.
Treatment groups
1,000 Participants
are divided into 3 treatment groupsGroup A: Carotid Endarterectomy (CEA)1 intervention
Group B: Carotid Artery Stenting (CAS)1 intervention
Group C: Hybrid Surgery1 intervention
Trial outcomes
Primary outcomes
1
Stroke or death whthin 30 days or recurrent ischemic stroke related of qualifying artery beyond 30 days through 12 months
Including TIA, minor stroke, moderate stroke, severe stroke, and fatal stroke
Time frame
Up to 12 months after procedure2
MMSE within 30 and 90 days after procedure
The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment. The MMSE's purpose has been not, on its own, to provide a diagnosis for any particular nosological entity.
Time frame
30 days and 90 days after procedure3
MoCA scale within 30 and 90 days after procedure
The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment.The MoCA test is a one-page 30-point test administered in approximately 10 minutes. The MoCA assesses: Short term memory/ Visuospatial abilities/ Executive functions/ Attention, concentration and working memory/ Language/ Orientation to time and place.
Time frame
30 days and 90 days after procedureSecondary outcomes
1
Technical success rate
Defined as the target vessel residual stenosis less than 30% by CTA
Time frame
Up to 24 hours after procedure2
Procedural success rate
Defines as the residual stenosis of the target vessel is less than 30% by CTA, and free of peri-procedural complications(includes cranial nerve injury, cardiac arrest, anaphylaxis, failure to recanalize blood vessels, distal embolism events, massive blood loss during operation, and residual thrombosis in the stent after operation)
Time frame
Up to 24 hours after procedure3
Any stroke within 30 days, 90 days and 12 months after procedure
Any stroke within 30 days, 90 days and 12 months
Time frame
Within 30 days, 90 days and 12 months post-procedure4
Death within 30 days, 90 days and 12 months after procedure
Death within 30 days, 90 days and 12 months
Time frame
Within30 days, 90 days and 12 months post-procedureSponsors and contacts
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Source ClinicalTrials.gov