Multi-dimensional Evaluation System for Recanalization of Symptomatic Non-acute Carotid Artery Occlusion

  • STATUS
    Recruiting
  • participants needed
    300
  • sponsor
    Beijing Tiantan Hospital
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Updated on 16 February 2024
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Summary

This is a multi-center, prospective, exploratory, observational, registration study on patients with symptomatic non-acute carotid artery occlusion to initially evaluate the safety and efficacy of endovascular treatment.

Description

Although patients with symptomatic carotid occlusion were primarily treated with medication, the risk of 2-year stroke recurrence was as high as 22.7%. Ipsilateral stroke and hemodynamic decline are independent risk factors for stroke recurrence in patients with carotid artery occlusion. In addition, long-term cerebral hypoperfusion and decreased cerebrovascular reactivity in patients with carotid artery occlusion may lead to cognitive impairment.

At present, the recanalization time window of anterior circulation large vessel occlusive stroke has been extended to 24 hours under certain evaluation approaches. In order to distinguish from the emergency treatment within 24 hours, patients with carotid artery occlusion over 24 hours are collectively referred as non-acute occlusion.

With the maturity of endovascular technique and the advances of interventional devices, endovascular treatment has become a hotspot of clinical research in this field. Case reports have emerged and prospective studies suggest that recanalization of chronic carotid occlusion may improve the cognitive functions. However, the clinical benefit of endovascular treatment for symptomatic non-acute carotid artery occlusion remained controversial.

The purpose of this study is to establish and verify the efficacy of a multi-dimensional evaluation system of endovascular treatment and recanalization of symptomatic non-acute carotid occlusion.

Details
Condition Carotid Artery Occlusion
Age 18years - 80years
Clinical Study IdentifierNCT04291430
SponsorBeijing Tiantan Hospital
Last Modified on16 February 2024

Eligibility

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Inclusion Criteria

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Age: 18-80 years old
Occlusion of the common carotid artery or internal carotid artery (TICI=0) confirmed by DSA
The origin of occlusive segment is from the common carotid artery or the initial segment of the internal carotid artery to the petrous segment and above, and does not exceed the bifurcation of the internal carotid artery (C7 segment). The distal occluded vessels, including the middle cerebral artery, have no severe stenosis or occlusion confirmed by angiography
Occlusion over 24 hours (confirmed by imaging or according to the patient's condition change)
Ischemic stroke, TIA or progressive visual impairment associated with occlusion
Small infarct showed by CT or MR examination (the maximum diameter of single infarct area 3cm), large hypoperfusion area indicated by CT perfusion (quantitative analysis with e-stroke software)
No severe neurological dysfunction (NIHSS 8 or Mrs 3) before procedure

Exclusion Criteria

Non-atherosclerotic occlusion (such as vasculitis, moyamoya disease, etc.)
Evidence of cardiogenic embolism
Allergic to heparin, aspirin, clopidogrel, statins, metals and anesthetics, or intolerant to general anesthesia
History of serious allergy to contrast media (excluding rash)
Untreated intracranial aneurysms, intracranial tumors (other than meningiomas) or any intracranial vascular malformations
Any history of intracranial hemorrhage (including cerebral parenchyma, ventricles, subarachnoid hemorrhage, subdural or extradural hemorrhage) within 30 days
History of primary cerebral parenchymal hemorrhage
Recent history of gastrointestinal bleeding with intolerance with antiplatelet therapy
Active bleeding constitution or coagulation disease, active peptic ulcer disease, systemic bleeding within 30 days, platelet count < 100 109 / L, hemoglobin < 9g / L, INR > 1.5, bleeding time more than the upper limit of normal value for 1 min, heparin-associated thrombocytopenia increases the risk of bleeding
Uncontrolled severe hypertension (systolic blood pressure > 180mmhg or diastolic blood pressure > 110mmhg)
Severe coronary heart disease, severe liver injury (AST or ALT more than 3 times of normal value), cirrhosis and severe renal insufficiency (creatinine > 177 mol / L)
Major surgery within 30 days or within the next 90 days
Known to have dementia or mental illness, and unable to complete neurological and cognitive assessment
Expected survival time1 year due to other diseases
Pregnant or lactating female
Included in other studies and in conflict with this study
Other special circumstances not suitable for endovascular surgery by consideration of neuro-physician, neurosurgeon, or neurointerventional
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