NCT01850056已完成不适用
Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure (AcoArt I Study)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Late Lumen Loss
研究概览
简要总结
The purpose of this study is to determine whether DEB is more effective than common PTA balloon in long-term vessel patency and inhibiting restenosis.
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
- •Age between 18 and 80 years
- •Patients with peripheral artery disease (PAD), with Rutherford classification between 2 and 5
- •an occlusion or a minimum grade of stenosisPrimary over 70% in the superficial femoral artery an /or the popliteal artery
- •Total length of treat lesion(s)is less or equal to 40cm
- •signed Patient informed consent form
排除标准
- •plasma Cr level greater than 150 umol/L in patients
- •patients with acute thrombosis requiring lysis or thrombectomy
- •patient with a lysis or an lower limb intervention as a therapy within the last 6 weeks
- •patient requiring intervention in both lower limbs at the same time
- •target lesion can't be cross by the guide wire
- •distal outflow through less than one lower leg vessel
- •known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
- •patients participating in another clinical trials with interfere with this trial in the past 3 months
- •pregnancy and lactating woman
- •untreatable bleeding diatheses
- •other diseases, such as cancer, liver disease, or cardiac insufficiency, which may lead to protocol violations or markedly shorten a patients's life expectancy(less than 2 years)
- •patients unable or unwilling to participate this trial
研究组 & 干预措施
drug eluting balloon catheter
Experimental
use drug eluting balloon catheter to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
干预措施: drug eluting balloon catheter (trade name: Orchid) (Device)
common balloon catheter(uncoated drug)
Active Comparator
use common balloon catheter to inflate stenosis or occlusion in SFA and/or popliteal artery
干预措施: common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral) (Device)
结局指标
主要结局
Late Lumen Loss
时间窗: 6 months
measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months
次要结局
- major amputation(6 months, 12 months, 18 months, 24 months)
- Minimal lumen diameter (MLD)(6 months)
- change in ankle brachial index(ABI)(6 months)
- change in Rutherford stage(6 months, 12 months, 18 months, 24 months)
- Restenosis rate of target vessel(6 months, 12 months, 18 months, 24months)
- target lesion revascularization(6 months, 12 months, 18 months, 24 months)
- Death(12 months, 18 months, 24 months)
研究者
研究点 (10)
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