Cerebral Arteriosclerosis
Conditions
Interventions
Experimental:Maurora stent implantation
Control:Apollo stent implantation
Sponsors
Beijing Tiantan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years; 2.Symptomatic arteriostenosis through the internal medicine treatment attributed to 70-99% stenosis of one of those cerebral arteries: Internal carotid artery (ICA ), M1 segment of the middle cerebral artery (MCA), vertebral artery, basilar artery, the stenosis diagnosed by CT/TCD/MRI/MRA/CTA and confirmed by DSA angiograph; 3.A target lesion length of <= 20 mm and the vessel diameter between 2.25mm and 5.0mm; 4.Only one target lesion to enroll in the study, and only one stent for the target lesion; 5.A Modified Rankin Score of <= 3; 6.With more than one atherosclerotic risk factors i.e., hypertension, diabetes, hyperlipidemia, hyperhomocysteinemia or smoking; 7.Written informed consent signed.
Exclusion criteria
Exclusion criteria: 1. Nonatheroscleotic stenosis related to disease such as: Moya Moya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with Cerebrospinal fluid (CSF) pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; post-partum angiopathy; suspected vasospastic process, suspected recanalized embolus; 2. Intracranial hemorrhage or hemorrhagic cerebral infarction within 6 weeks, or massive cerebral infarcts in the angiopathic area (more than 1/3 area), or complete stroke; 3. Complicated with atrial fibrillation, valvular heart disease, left ventricular thrombus or myocardial infarction within 6 weeks causing cardiogenic stroke; 4. Complicated with tumor, arteriovenous malformation or aneurysm; 5. Known allergy or contraindication to heparin, aspirin, Ticlopidine Hydrochloride (antiplatelets), contrast dye and metal; 6. Contraindication to aspirin and clopidogrel; 7. Hemoglobin 1.5, non-iatrogenic and uncorrectable bleeding tendency; 8. Major surgery within previous 30 days or planned in the next 90 days after enrollment; 9. Clinical and imaging evaluation incapable of determenting the target vessel responsible for symptoms; 10. Occlusion of target lesion; 11. Severe calcification, intraluminal thrombus, diffuse or tendom stenosis; 12. Major gastrointestinal bleeding within 90 days, contraindication to antiplatelet agents and anticoagulants incapable of antithrombotic therapy, with bleeding tendency; 13. Heart failure, severe renal and hepatic insufficiency; 14. Co-morbid conditions that may limit survival to less than 12 months; 15. Pregnant or lactating female; 16. Enrollment in another study that would conflict with the current study; 17. Unable or unwilling to enroll in study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent restenosis rate within 180 days after Implantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrent Ischemic Stroke and TIA in the Target Territory;Technical success rate;Procedural success rate of delivery system; | — |
Countries
China
Contacts
Public ContactMiao Zhongrong
Beijing Tiantan Hospital
Outcome results
None listed