Skip to content

A prospective, randomized controlled, single-center clinical study of EC-IC bypass in the treatment of symptomatic intracranial arteries atherosclerotic stenosis

A prospective, randomized controlled, single-center clinical study of EC-IC bypass in the treatment of symptomatic intracranial arteries atherosclerotic stenosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000028929
Enrollment
Unknown
Registered
2020-01-08
Start date
2020-01-09
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic intracranial arteries atherosclerotic stenosis

Interventions

surgical group:STA-MCA bypass

Sponsors

The Third Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients can cooperate with the examination and follow-up on the premise of knowing the research contents, and sign the informed consent completely voluntarily; 2. Aged >= 18, 50%) were intracranial large vessels, including intracranial segment of internal carotid artery and M1 segment of middle cerebral artery. No adequate collateral circulation.No moyamoya disease (MMD); The ipsilateral superficial temporal artery shows clearly in CTA. At least one radial artery is negative in Allen test; 4. The patient has symptoms of cerebral ischemia caused by vascular lesions, including ischemic stroke: cerebral blood supply disorders caused by various causes ,which lead to cerebral ischemia, hypoxia-deficient necrosis of brain, and corresponding neurological defects; Transient ischemic attack; 5. Patient's syptom is due to atherosclerosis; 6. NHISS score < 9; 7. Modified Rankin scale score mRs <= 3 points; 8. Have at least one risk factor for atherosclerosis: hypertension, diabetes, hyperlipidemia and hyperhomocysteemia, or a history of smoking, family history of atherosclerosis ; 9. CTP showed decreased cerebral blood perfusion in the vascular supply area of stenosis, such as decreased CBF, increased or decreased CBV, prolonged MTT and prolonged TTP, and insufficient collateral circulation compensation.

Exclusion criteria

Exclusion criteria: 1. Acute ischemic stroke occurred within 4 weeks, which was confirmed by clinical symptoms or CTA or DSA images; Or a large area of cerebral infarction with a diameter of >5mm in the stenosis related area; 2. Stroke caused by occlusion of the perforating artery confirmed by medical imaging; 3. Patients with severe systemic diseases, such as severe diabetes, coronary heart disease, blood system diseases, etc. 4. Patients with a previous history of atrial fibrillation, infective endocarditis or rheumatic endocarditis, and with left atrial mural thrombosis and/or mitral and aortic valve vegetations confirmed by echocardiography; 5. Patients with stenosis or occlusion of large intracranial vessels (vertebral artery and basilar artery,> 50%); Patients with major arteries (common carotid artery, descending aorta etc.) of atherosclerotic plaque formation confirmed by vascular ultrasound and angiography, with the risk of detachment; 6. Patients' intracranial arterial stenosis wasn't caused by atherosclerotic, including: artery dissection, Moyamoya disease, vasculitis, herpes zoster, varicella zoster disease or other viral vascular disease and nerve syphilis, any other intracranial infection, associated with pleocytosis any intracranial stenosis, vascular lesions induced by radiation, muscular fiber dysplasia, sickle cell disease, neurofibromatosis, benign vascular disease of the central nervous system, postnatal vascular disease, suspected of vasospasm, suspicious embolus recanalization; 7. Cardiogenic stroke or potential cardiogenic thrombosis; 8. Any cerebral parenchyma or other intracranial subarachnoid space, subdural or epidural exudation within 4 weeks; 9. Myocardial infarction within 4 weeks; 10. History of bleeding within 4 weeks; 11. Patients who have undergone major surgery within 4 weeks; 12. Patients who are accompanied by intracranial tumors, aneurysms or arteriovenous malformations; 13. Patients who have allergies to experimental and surgical drugs (heparin, contrast agents, aspirin and clopidogrel, etc.) or operating devices, or allergic constitution; or patients can't take the above-mentioned drugs; 14. Patients cannot take general anesthesia; 15. Women who are pregnant or breastfeeding, or who plan to become pregnant within one year; 16. Patients' Hemoglobin 400mg/dl (22.2mmol/L); Genetic or acquired hemorrhagic constitution, lack of anticoagulant factors; Or had received anticoagulant therapy before randomization and INR> was 1.7. 17. Patients restenosis after intracranial arterioplasty; 18. Patients with poor general condition, estimated survival time < 3 years; 19. Patients' Follow-up is not expected to be completed; Or patients are participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
cerebral blood perfusion;

Countries

China

Contacts

Public ContactWang Hui

Department of Neurosurgery, the Third Affiliated Hospital, Sun Yat-Sen University

doctorwanghui@126.com+86 13763322020

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026