Non-acute symptomatic intracranial atherosclerotic stenosis
Conditions
Interventions
control group:Intracranial balloon dilatation cathete
Sponsors
The First Affiliated Hospital of China University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) 18 to 80 years old; 2) Symptomatic intracranial artery stenosis, and the degree of target vessel diameter stenosis under intracranial angiography is between 70% and 99% (WASID method); 3) Stenotic vessels are located in internal carotid artery (intracranial segment), middle cerebral artery, basilar artery and vertebral artery (intracranial segment); 4) The patient has at least one risk factor for intracranial atherosclerosis, including past or existing hypertension, hyperlipidemia, diabetes and smoking; 5) mRS=2 points before joining the group; 6) Intracranial artery stenosis requiring interventional therapy is a single lesion; 7) Patients or their guardians can understand the purpose of the trial, voluntarily participate in and sign a written informed consent form, and can be followed up.
Exclusion criteria
Exclusion criteria: 1) The target blood vessel is severely calcified and twisted, so it is difficult to put interventional instruments in place or recover them; 2) Acute ischemic stroke occurred within 2 weeks before operation; 3) Cerebral hemorrhage occurred 3 months before operation; 4) The target lesion has been treated with interventional therapy before; 5) Tandem lesions with non-target lesion stenosis greater than 70%; 6) Long segmental lesions larger than 16mm; 7) Intracranial artery stenosis caused by non-atherosclerotic lesions; 8) Intracranial aneurysm or intracranial arteriovenous malformation with unpredictable high risk or bleeding risk; 9) Risk factors that can lead to the risk of cardiogenic embolism (such as left ventricular thrombosis and one-month myocardial infarction); 10) History of gastrointestinal bleeding within 6 months; 11) coagulation dysfunction or obvious bleeding tendency (such as INR > 1.5); 12) Known allergic history to contrast agents, anticoagulants, anesthesia and other drugs; 13) platelet count (PLT 180mmHg or diastolic blood pressure > 110mmhg); 16) creatinine > 3mg/dL, that is > 265 µ mol/l; 17) serious dysfunction of important organs such as heart, liver and kidney; 18) Those who are participating in clinical trials of other drugs or devices and have not reached the main end point; 19) pregnant or lactating women, or those who plan to get pregnant within one year; 20) Life expectancy is less than 1 year; 21) The researcher judges that there are other situations that are not suitable for joining the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restenosis rate of target lesion at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average lumen diameter stenosis degree at 6 months after operation;Restenosis rate of target lesion 12 months after operation;Instrument success rate;Operation success rate;Incidence of ischemic stroke and hemorrhagic stroke 30 days after operation;Incidence rate of ischemic stroke and hemorrhagic stroke in target vessels from 30 days to 6 months after operation;Incidence of ischemic stroke and hemorrhagic stroke in 12 months after operation;Incidence rate of all-cause death at 30 days, 6 months, 12 months and 24 months after operation.;Changes of NIHSS score within 7 days (before discharge) and 6 months after operation.;Changes of mRS score at 30 days, 6 months, 12 months and 24 months after operation;Incidence of serious adverse events and incidence of adverse events; | — |
Countries
China
Contacts
Public ContactWei Hu
The First Affiliated Hospital of China University of Science and Technology
Outcome results
None listed