Revascularization for Symptomatic Non-acute Carotid Artery Occlusion

Recruiting now

Conditions studied: Non-acute Carotid Artery Occlusion

In brief

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.

Key facts

Study ID

NCT06303414

Run by

Xuanwu Hospital, Beijing

People needed

1000

Starts

2016-06-17

Expected to finish

2028-12-30

Last updated by the study team

2024-03-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

• Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Xuanwu Hospital, Capital Medical University. — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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