Non-acute symptomatic intracranial atherosclerotic stenosis
Conditions
Interventions
Experimental Group:Drug balloon dilatation catheter
Control group :Intracranial balloon dilation catheter
Sub research:Drug balloon dilatation catheter
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18 to 80 years old (including the threshold), gender not limited. 2. Symptomatic intracranial artery stenosis, with the degree of stenosis of the intracranial lesion artery measured by cerebral angiography ranging from 70% to 99% (WASID method); 3. The narrowed vessels are located in the intracranial segment of the internal carotid artery, the middle cerebral artery (M1, M2), the basilar artery, and the intracranial segment of the vertebral artery. 4. The intracranial artery stenosis lesion requiring interventional treatment is a single lesion; 5. At least one atherosclerotic risk factor is present, with atherosclerotic etiology considered, including previous or existing hypertension, diabetes, hyperlipidemia, hyperurea, hyperhomocysteine, smoking, and alcohol consumption. 6. mRS<=2 points during the screening period; 7. The subject or their guardian can understand the purpose of the trial, voluntarily participate and complete the written informed consent, and be able to accept and complete the follow-up on time.
Exclusion criteria
Exclusion criteria: 1. The target lesion is an in-stent restenosis lesion or a restenosis lesion after balloon dilation; 2. Those with other intracranial artery stenosis or occlusion that require interventional or surgical treatment; 3. Those who have experienced intracranial hemorrhage (parenchymal hemorrhage, subarachnoid hemorrhage, subdural/external hemorrhage) within 3 months; 4. Those who have experienced acute ischemic stroke within the past two weeks; 5. Stenosis not caused by atherosclerosis: such as arterial dissection, moya-moya disease, vasculitis, active arteritis, etc. 6. Severe calcification lesions and keratosis lesions, Mori type C lesions; 7. Combined with intracranial tumors, aneurysms or intracranial arteriovenous malformations; 8. There are risk factors that may lead to cardiogenic embolism, such as atrial fibrillation, left ventricular thrombosis, acute myocardial infarction within 2 weeks, etc. Those who have undergone intravascular treatment of intracranial arteries within 9.2 weeks; 10. Hypertension that cannot be controlled by drug treatment (systolic blood pressure persistently > 180mmHg or diastolic blood pressure persistently > 110mmHg); 11. Severe comorbidities or unstable conditions, such as severe heart failure, lung failure or kidney failure (serum creatinine >3.0mg/dL (265µmol/L)), severe liver dysfunction (ALT or AST more than three times the normal value), and malignant tumors; 12. There is a history of gastrointestinal bleeding or hemorrhagic diseases (such as idiopathic thrombocytopenic purpura, etc.) or a history of bleeding tendency within 6 months prior to signing the informed consent form; 13. Hemoglobin is lower than 90g/L, and platelet count is less than 90*109/L; 14. International normalized ratio (INR) >1.5, with uncorrectable bleeding factors; 15. Antiplatelet/anticoagulant therapy cannot be performed; 16. Angiography shows that the vascular path is tortuous, and the test instrument is difficult to reach the target position or be retrieved. 17. Patients who are known to be allergic to heparin, paclitaxel, contrast agents, aspirin, clopidogrel and anesthetics; 18. Life expectancy is less than one year; 19. Those who are currently or plan to participate in clinical trials of other drugs or devices during the trial period; 20. Pregnant or lactating women, or those planning to become pregnant within one year; 21. Those who the researchers consider to have other circumstances that make them unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restenosis of target lesion ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Stenosis degree of lumen diameter 6 months/12 months after operation ;Restenosis of target lesion 12 months after operation ;Modified Rankin Score (mRS) ; | — |
Countries
China
Contacts
Public ContactJianmin Liu
Shanghai Changhai Hospital
Outcome results
None listed