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

Beijing Tiantan Hospital300 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Carotid Artery Occlusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Sign the informed consent form 2. Age: 18-80 years old; 3. Occlusion of the common carotid artery or internal carotid artery (mTICI=0) confirmed by DSA 4. 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 5. Occlusion over 24 hours (confirmed by imaging or according to the patient's condition change) 6. Ischemic stroke, TIA or progressive visual/cognition impairment associated with occlusion 7. Distinguishable hypoperfusion area indicated by CT perfusion (CBF decrease) Exclusion Criteria: 1. Target vessel occlusion caused by radiotherapy, vasculitis, moyamoya disease. 2. Any history of intracranial hemorrhage (imaging confirmed or medical record confirmation, except for SWI recorded micro-bleeding) within 3 months. 3. Large core infarction history or index stroke caused by large core infarction (infarct volume \>70ml, or exceeding the MCA territory \>1/3, or middle cerebral structural shifting) 4. Disabling before index event (mRS\>3) 5. History of serious allergy to contrast media (excluding rash), allergic to heparin, aspirin, clopidogrel, statins, metals and anesthetics, or intolerant to general anesthesia 6. Target vessel tortuous or complex vasculature which may cause procedural difficulty 7. Combined with untreated severe coronary artery stenosis or occlusion, untreated intracranial aneurysms, intracranial tumors (other than meningiomas) or any intracranial vascular malformations 8. Gastrointestinal or urinary bleeding, AMI, craniocerebral trauma, major surgery within 30 days 9. Active bleeding constitution or coagulation disease, platelet count \< 50 × 10\^9 / L 10. Uncontrolled hypertension (systolic blood pressure \> 185mmhg), GLU\<2.8 mmol/L, GLU\>18mmol/L 11. Severe cardiac insufficiency, severe liver injury (AST or ALT more than 3 times of normal value), severe renal insufficiency (creatinine \> 177 μ mol / L)， and other late-stage disease 12. Known to have dementia or mental illness, and unable to complete neurological and cognitive assessment 13. Expected survival time\<1 year 14. Pregnant or lactating female 15. Included in other studies and in conflict with this study 16. Other special circumstances not suitable for endovascular surgery by consideration of neuro-physician, neurosurgeon, or neurointerventional

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Recurrence of ischemic stroke related to target vessels within 12 months after procedure

Including TIA, minor stroke, moderate stroke, severe stroke and fatal stroke

Time frame: 12-month after procedure

NIHSS within 12 months after procedure

NIHSS. The NIH Stroke Scale measures several aspects of brain function, including consciousness, vision, sensation, movement, speech, and language.A certain number of points are given for each of these physical and cognitive functions during a focused neurological examination. A maximal score of 42 represents the most severe and devastating stroke. The level of stroke severity as measured by the NIH stroke scale scoring system: 0 = no stroke 1-4 = minor stroke 5-15 = moderate stroke 15-20 = moderate/severe stroke 21-42 = severe stroke

Time frame: 12-month after procedure

mRS within 12 months after procedure

The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. (Score Description: 0---No symptoms at all. 1---No significant disability despite symptoms; able to carry out all usual duties and activities. 2---Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. 3---Moderate disability; requiring some help, but able to walk without assistance. 4--- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5---Severe disability; bedridden, incontinent and requiring constant nursing care and attention. 6---Dead.

Time frame: 12-month after procedure

EQ-5D scale within 12 months after procedure

The EQ-5D essentially consists of two pages: the EQ-5D descriptive system and the EQ-5D visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems (labelled 1-3). The respondent is asked to indicate his / her health state by checking the box against the most appropriate statement in each of the five dimensions. The EQ VAS records the respondent's self-rated health on a vertical VAS where the endpoints are labelled 'The best health you can imagine'( score as 100) and 'The worst health you can imagine' (score as 0). This information can be used as a quantitative measure of health outcome as judged by the individual respondents.

Central Contacts

Dapeng Mo, PhD

CONTACT

+86 13691419036 modapeng1971@163.com

Data from ClinicalTrials.gov

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Secondary Outcomes

Technical success rate

Defined as the target vessel residual stenosis less than 50% and mTICI grade ≥ 2b

Time frame: Up to 24 hours after procedure

Procedural success rate

Defines as the residual stenosis of the target vessel is less than 50%, and the TICI grade is ≥ 2b, and free of peri-procedural complications.

Time frame: Up to 24 hours after procedure

Recurrence rate of ischemic stroke related to culprit vessel within 30 and 90 days after procedure

Including TIA, minor stroke, moderate stroke, severe stroke and fatal stroke