Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure of Vertebral Artery Ostium Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Rate of device success
研究概览
简要总结
The purpose of this study is to determine whether DEB is not inferior to common bare metal stent using under in long-term vessel patency and inhibiting restenosis in Vertebral Artery Ostium Stenosis
详细描述
Vertebral Artery Origin Stenting is an established alternative to open surgical bypass for the treatment of Vertebral Artery Ostium Stenosis .
DEBs are designed to promote arterial patency by reducing neointimal proliferation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 18 and 80 years old
- •symptomatic VAO stenosis refractory to AMM (aggressive medical management)
- •etiology of VAOS was atherosclerosis
- •the diameter of the normal segment of the artery beyond the stenosis between 3mm and 5mm
- •Target lesion has stenosis ≥ 70% evidenced by angiography
- •Score on the modified Rankin scale ≤ 3
- •Patients have signed informed consent
排除标准
- •In-stent restenosis in vertebral artery
- •Severe calcified lesion or residual stenosis ≥30% after predilatation or flow-limiting dissection
- •Tortuous or variable vessels
- •distal serial stenosis or distal vascular dysplasia of the stenosis segment
- •Non-atherosclerotic arterial stenosis
- •Non-vertebral artery stenosis caused TIA or stroke
- •intracranial stent implantation within 12 months
- •Intracranial hemorrhage occurred within 3 months
- •Obvious thrombosis in brain vessel, or have received thrombolytic therapy 24 hours before procedure
- •Active bleeding or coagulation disorders
- •Serious liver/kidney damage, not suitable for routine surgical treatment
- •Myocardial infarction or extensive cerebral infarction occurred within 2 weeks
- •Uncontrolled high blood pressure
- •Complicated intracranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm
- •Potential sources of cardiogenic thrombosis, such as mitral stenosis, atrial septal defect, aorta or mitral valve replacement, left atrial myxoma, etc
- •Life expectancy shorter than 1 years
- •Patients whit cognitive impairment or mental disorders
- •Known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc
- •Pregnant and lactating women
- •Patients who have participated in other clinical trials during the same period that lead to researchers who believe that patients may not be able to follow the trial program
结局指标
主要结局
Rate of device success
时间窗: during the operation
DEB group: DEB catheter can reach the target lesions, expand as expected (not broken),and withdraw successfully. BES group: the stenosis rate of proximal outflow less than 50% with intervention and no ischemia or hemorrhage occurred.
Rate of target lesion restenosis
时间窗: 12Months
Target Lesion Restenosis（diameter stenosis ≥50%） under DSA at 12 Months or diamater stenosis ≥50% under DSA before Target Lesion Revascularization within 12 Months
次要结局
- Rate of device success(during the operation)
- Incidence of transient ischemic attack of posterior circulation(12 Months)
- Incidence of hemorrhagic stroke and posterior circulation ischemic stroke(12 Months)