Real-World Registry Assessing the Clinical Use of the Orchid Drug Coated Balloon Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- Primary patency of target lesion.
研究概览
简要总结
The registry is a prospective, multicenter, single arm post-market real-world registry in China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).
详细描述
PTA is an established alternative to open surgical bypass for the treatment of infrainginual disease of critical limb ischemia.
DEBs are designed to promote arterial patency by reducing neointimal proliferation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 20cm
- •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
- •2 or more than 2 stenosis lesions in traget vessel
- •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
- •have >30% residual stenosis or blood-limited dissection after predilation
- •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 1 years)
- •patients unable or unwilling to participate this trial
结局指标
主要结局
Primary patency of target lesion.
时间窗: 12 months
The primary efficacy end point was primary patency at 12 months following the index procedure, defined as freedom from clinically driven target lesion revascularization and restenosis as determined by a duplex ultrasonography-derived peak systolic velocity ratio of ≤2.4
次要结局
- target lesion revascularization,target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion(6 months, 12 months)
- improvment in Rutherford stage(6 months, 12 months)
- change in ankle brachial index(ABI)(12 months)
- Device success during the operation(during the operation)