Symptomatic intracranial atherosclerotic stenosis
Conditions
Interventions
Experimental group:Intracranial Laser Balloon Dilation Catheter and Laser Generator of Hangzhou Juzheng Medical Technology limited company
Control group:Gateway PTA Balloon Catheter of Boston Scientific Corporation
Observation group:Intracranial Laser Balloon Dilation Catheter and Laser Generator of Hangzhou Juzheng Medical Technology limited company
Sponsors
The First People’s Hospital of Changzhou; The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age 18 to 80 years old; (2) Symptomatic intracranial artery stenosis, the diameter of the target vessel measured by intracranial angiography was between 70 and 99% (WASID method); (3) The stenosis vessels were in internal carotid artery (intracranial segment), middle cerebral artery, basilar artery, vertebral artery (intracranial segment); (4) The patient had at least one risk factor for intracranial atherosclerosis, including past or existing hypertension, hyperlipidemia, diabetes, smoking, etc.; (5) mRS<=2 before enrollment; (6) 1.25mm<= target vessel diameter <=4.5mm; (7) Intracranial artery stenosis requiring interventional treatment was a single lesion; (8) Patients or their guardians can understand the purpose of the trial, voluntarily participate and sign a written informed consent, and can accept follow-up.
Exclusion criteria
Exclusion criteria: (1) The target vessel is severely calcified and distorted, and the interventional instruments are difficult to be in place or recovered; (2) Acute ischemic stroke occurred within 2 weeks before surgery; (3) Cerebral hemorrhage occurred 3 months before surgery; (4) The target lesion has been treated with interventional therapy before; (5) Intracranial artery stenosis caused by non-atherosclerotic lesions; (6) Intracranial aneurysm or intracranial arteriovenous malformation with an unpredictable high risk or risk of bleeding; (7) Risk factors that may contribute to the risk of cardiogenic embolism (such as left ventricular thrombosis, myocardial infarction within 1 month); (8) History of gastrointestinal bleeding within 6 months; (9) Coagulation dysfunction or obvious bleeding tendency (such as INR > 1.5); (10) Known allergy to contrast agents, anticoagulants, anesthesia and other drugs, red light; (11) Platelet count (PLT180mmHg or diastolic >110mmHg); (14) Creatinine >3mg/dL, i.e. >265µmol/L; (15) Serious dysfunction of important organs such as heart, liver and kidney; (16) Those who are participating in clinical trials of other drugs or devices that do not meet the primary endpoint; (17) Women who are pregnant or breastfeeding, or who plan to pregnant within one year; (18) Life expectancy is less than 1 year; (19) The researcher determined that there were other circumstances that were not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immediate residual stenosis after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Restenosis rate of target lesion after 6 months operation;The success rate of operation;Apparatus success rate;Changes in NIHSS score within 7 days after surgery or before discharge;Changes in mRS at 6 months after surgery;Incidence of ischemic stroke and hemorrhagic stroke at 30 days and 6 months after surgery;Mortality at 30 days and 6 months after surgery;Incidence of device defect;Serious adverse event rate, adverse event rate; | — |
Countries
China
Contacts
Public ContactPeng Ya; Guan Sheng
The First People’s Hospital of Changzhou&The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed