Intracranial atherosclerotic stenosis
Conditions
Interventions
Trial group:Intracranial drug-eluting stent (Shanghai Xinwei Medical Technology Co., Ltd.)
Control group:Wingspan Stent System (Stryker (Beijing) Medical Equipment Co., Ltd.)
Sponsors
Henan Provincial People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years and = 80 years, male or female; 2. Patients with symptomatic intracranial atherosclerotic stenosis who failed medical treatment or had low perfusion in the target vessel area, with target lesion stenosis degree of 70% = and = 99%; 3. The lesion to be treated is a single target lesion, located in the intracranial segment of the internal carotid artery, middle cerebral artery, intracranial segment of the vertebral artery, basilar artery, etc.; 4. The reference vessel diameter range of the target lesion is 1.5-5.0mm, and the lesion length is =34mm; 5. Patients with mRs score = 2; 6. Patients who are considered suitable for stent endovascular treatment by the researcher; 7. Patients or their guardians voluntarily participate and sign a written informed consent form, and can accept the examinations and follow-ups specified by the protocol.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received endovascular intervention (except simple balloon angioplasty) or surgical treatment for the target lesion; 2. Patients with symptomatic carotid stenosis = 50% outside the target lesion, or patients with = 70% stenosis in other intracranial or extracranial vessels that need treatment; 3. Stroke caused by isolated perforator artery occlusion; 4. Patients who have had acute ischemic stroke or severe myocardial infarction within 14 days before surgery; 5. Patients who have had intracranial hemorrhage within 3 months before surgery; 6. Patients with severe calcification, severe distortion, or extreme bending of the target lesion, who are assessed by the researcher as unsuitable for device use; 7. Patients with severe stenosis, tortuosity, or anatomical abnormalities of the intracranial artery, who are assessed by the researcher as difficult to reach the lesion site with the device; 8. Patients with intracranial tumors, arteriovenous malformations, hematomas, or tandem aneurysms at the proximal and distal ends of the target lesion; 9. Patients with known uncontrolled hypertension (systolic blood pressure persistently = 180mmHg or diastolic blood pressure persistently = 110mmHg); 10. Patients with known contraindications to antiplatelet or/and anticoagulant therapy; 11. Patients with known significant coagulation dysfunction or bleeding tendency, who are judged by the researcher as unsuitable for surgery; 12. Patients with known severe liver or kidney dysfunction (AST or ALT more than 3 times the upper limit of normal range; creatinine > 1.5 times the upper limit of normal value); 13. Patients with a clear history of allergy to rapamycin, polylactic acid-hydroxyethyl acrylate copolymer, polybutyl methacrylate, boron reagent, nickel-titanium and other materials; 14. Patients with severe allergy to anesthetic drugs or contrast agents (rash not included); 15. Patients with an expected life span of less than 2 years; 16. Pregnant or lactating women; 17. Patients who are participating in other clinical trials of drugs or devices and have not completed the primary endpoint follow-up; 18. Patients who are assessed by the researcher as unsuitable for participating in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of in-stent restenosis at 6 months postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Equipment operation success rate;Surgical success rate;Rate of in-stent restenosis at 12 months post-operation;Rate of symptomatic in-stent restenosis at 6 months and 12 months post-operation;Modified Rankin Score (mRS) at 30 days, 6 months, and 12 months post-operation;NIHSS score pre-operation, post-operation to discharge, and at 6 months post-operation;Target lesion revascularization rate at 30 days, 6 months, and 12 months post-operation;Stroke incidence rate at 30 days, 6 months, and 12 months post-operation;All-cause mortality rate at 30 days, 6 months, 12 months, and 24 months post-operation;Rate of device-related adverse events/serious adverse events at 30 days, 6 months, 12 months, and 24 months post-operation;Equipment defect rate; | — |
Countries
China
Contacts
Public ContactTianxiao Li
Henan Provincial People’s Hospital
Outcome results
None listed