vertebral artery stenosis
Conditions
Interventions
Balloon-expandable stent group:Drug-eluting stent group
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must be beyond 18-year old; 2. Patients with at least one antiplatelet drug treatment, still suffer ipsilateral transient ischemic attack (TIA) and stroke, which result from intracranial severe vertebral artery stenosis (70-99%), and patients have extracranial vertebral artery stenosis (70-99%); 3. Target lesion in length is 20 mm or less, and target artery reference diameter must be 2.25 mm to 5.0 mm; 4. Only one target lesion is included, which can be solved by one stent; 5. the modified rankan scale (mRS) ?3 before last event; 6. At least one atherosclerotic risk factor (hypertension, diabetes mellitus, dyslipidemia, hyperhomocysteinemia, and cigarette smoking) is present; 7. Patiens understand the purpose and requirement of the study and have signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Tandem vertebrobasilar severe stenosis (>70%) or occlusion that is proximal or distal to the target vertebral artery; 2. Non-atherosclerotic occlusion: arterial dissection, moya-moya disease; vasculitic disease;herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis;any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy;fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of centralnervous system; postpartum angiopathy;suspected vasospastic process,and suspected recanalized embolus. arterial dissection, moya-moya disease; vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy;fibromuscular dysplasia;sickle cell disease; neurofibromatosis; benign angiopathy of centralnervous system;postpartum angiopathy; suspected vasospastic process, and suspected recanalized embolus; 3. Previous spontaneous intracerebral (parenchymal) or other intracranial (subarachnoid, subdural, orepidural) hemorrhage within 6 weeks; 4. Chronic atrial fibrillation;any episode of paroxysmal atrial fibrillation within the past six months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulationand other cardiac sources of emboli such as left ventricular aneurysms,intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcified aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, left atrial myxoma; 5. Intracranial aneurysmtumors or any intracranial vascular malformations; 6. Allergic reaction to any of the medical therapy, including aspirin, clopidogrel, heparin, sirolimus, contrast, and local or general anesthetics; 7. Recent gastrointestinal bleed that would interfere with antiplatelet therapy 8. Active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets 1.5, clotting factor abnormality that increases the risk of bleeding, current alcohol or substance abuse, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115 mm Hg), severe liver impairment Aspartate Transaminase (AST) or Alanine transaminase (ALT) > 3 x normal, cirrhosis, creatinine>265.2 mmol/l (unless on dialysis); 9. Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment; 10. Calcified plaque difficult to be diluted, or embolism in target lumen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perioperative complication;in-stent restenosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| ipsilateral stroke;all adverse events; | — |
Countries
China
Contacts
Public ContactTianxiao Li
Henan Provincial People's Hospital
Outcome results
None listed