NCT03504657Unknown2 期
Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis
The First Affiliated Hospital of Zhengzhou University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年5月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Restenosis
研究概览
简要总结
Posterior circulation stroke accounts for 20% of ischemic stroke. A quarter occurs in patients with stenosis in the vertebral and/or basilar arteries. Vertebral artery stenosis can be treated with stenting. However, in-stent restenosis rate have been reported as high as more than 30%, which may reduce the effect of stent therapy. Drug-coated balloon has shown good results in controlling neointimal hyperplasia in the femoral and popliteal arteries.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Patients presenting with posterior circulation transient ischemic attack or nondisabling stroke in the previous 6 months
- •Vertebral artery origin stenosis resulting from presumed atheromatous disease with stenosis ≥50%
- •Lesion length of the stenosis >5mm.
- •Angioplasty can be performed within two weeks after randomization
- •Female subjects of childbearing potential have a negative pregnancy test.
- •Signed informed consent prior to entering study
排除标准
- •Potential cause of TIA or minor stroke other than stenosis in a vertebral artery (e.g. atrial fibrillation)
- •Life expectancy shorter than 2 years
- •Vertebral artery stenosis caused by dissection
- •Vertebral stenting felt to be technically impracticable
- •Previous stenting in randomized artery
- •Pre-morbid modified Rankin scale score of greater than 3
- •Currently participating or previously participated in any investigational drug or device study within 6 months.
研究组 & 干预措施
Drug-coated balloon angioplasty
Experimental
干预措施: Drug-coated balloon angioplasty (Device)
stenting angioplasty
Active Comparator
干预措施: stenting angioplasty (Device)
结局指标
主要结局
Restenosis
时间窗: 12 months
次要结局
- The composite of vascular death, myocardial infarction, or any stroke(within 12 months after the start of treatment)
- Death resulting from any cause(12 months)
- Stroke in the supply territory of the symptomatic vertebral artery(12 months)
研究者
Chuanjie Wu
MD
The First Affiliated Hospital of Zhengzhou University
研究点 (2)
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