intracranial atherosclerotic stenosis
Conditions
Interventions
Test Group: a single-use intracranial drug balloon
control group:Intracranial balloon dilatation catheter
Sponsors
Nanjing Gulou Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 years (inclusive), regardless of gender. 2. Diagnosed with symptomatic intracranial atherosclerotic stenosis, with target vessel diameter stenosis of 70% to 99% confirmed by intracranial angiography (WASID criteria). 3. Planned to undergo balloon angioplasty for a single primary intracranial arterial stenosis lesion, including the internal carotid artery (intracranial segment), middle cerebral artery, basilar artery, or vertebral artery (intracranial segment). 4. Patients who experienced =1 episode of stroke or transient ischemic attack (TIA) despite intensive medical therapy (including antiplatelet, antihypertensive, hypoglycemic, and lipid-lowering therapies); or patients with insufficient collateral circulation (meeting at least one of the following criteria):ASITN/SIR collateral flow score =2.00 mm and target lesion length =19 mm. 6. Modified Rankin Scale (mRS) score <=2. 7. Capable of comprehending the study objectives, voluntarily participating, and providing written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with active peptic ulcer or history of gastrointestinal bleeding within 6 months prior to enrollment. 2. Patients undergoing major surgery (including open femoral artery, aortic, or carotid artery surgery) within 1 month before enrollment or planning such surgery within 6 months. 3. Patients with a history of intraparenchymal, subarachnoid, subdural, or epidural hemorrhage within 3 months prior to enrollment. 4. Patients with risk factors for cardioembolism (e.g., atrial fibrillation within the past 6 weeks, concomitant left ventricular thrombus). 5. Patients with myocardial infarction within 4 weeks prior to enrollment. 6. Patients with acute ischemic stroke within 2 weeks prior to enrollment. 7. Patients receiving thrombolytic therapy within 24 hours prior to enrollment. 8. Patients with significant bleeding tendency or uncorrectable coagulation disorders (platelet count 1.5). 9. Patients with active infection. 10. Patients with severe hepatic or renal dysfunction (ALT >3×upper limit of normal [ULN], AST >3×ULN, or creatinine >1.5×ULN) or history of major organ dysfunction (e.g., cardiac, pulmonary, renal, or cerebral). 11. Patients with uncontrolled severe hypertension (persistent systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg). 12. Patients with stenosis caused by non-atherosclerotic etiologies (e.g., arterial dissection, moyamoya disease, vasculitis, active arteritis, or thrombosis). 13. Patients with intracranial tumors, aneurysms, or arteriovenous malformations. 14. Patients with tandem stenosis or occlusion >=70% proximal or distal to the target lesion. 15. Patients with cerebral artery spasm without significant stenosis. 16. Lesions unsuitable for adequate pre-dilation (residual stenosis >50% post-pre-dilation or flow-limiting dissection), such as severe fibrosis or calcification. 17. Patients with tortuous target vessels on angiography that may impede delivery or retrieval of interventional devices. 18. Patients requiring concurrent non-target lesion intervention or other procedures (e.g., coronary, renal, or iliac artery interventions). 19. Patients with known hypersensitivity or intolerance to contrast agents, paclitaxel or its analogs, anticoagulants/antiplatelet agents, or anesthetics. 20. Patients currently participating in other interventional drug or medical device clinical trials. 21. Pregnant or lactating women, or those planning pregnancy within 1 year. 22. Patients with a life expectancy <2 years. 23. Patients deemed ineligible by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The restenosis rate of the target lesion at 6 months after the operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate;Technical success rate;The restenosis rate of the target lesion 12 months after the operation;The changes in the National Institutes of Health Stroke Scale (NIHSS) scores compared with the baseline before discharge or within 7 days after the operation, at 6 months and 12 months after the operation;The changes in the modified Rankin Scale (mRS) scores compared with the baseline at 1 month, 6 months, and 12 months after the operation, and the proportion of patients with an mRS score of = 2 points.;Evaluation of Instrument Performance; | — |
Countries
China
Contacts
Public ContactXu Yun
Nanjing Gulou Hospital
Outcome results
None listed