NCT03505931Unknown不适用
Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease (K-ELUVIA Registry)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary patency
研究概览
简要总结
- Prospective, multi-center single-arm observational study
- A total of 100 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included.
- Patients will be followed clinically for 12 months after the procedure.
- An imaging study (duplex ultrasound, CT or catheter-based angiography) follow-up according to participating hospital's protocol will be performed at 12 months.
- Ankle-brachial index, symptom status and presence of stent fracture will be evaluated at 12 months.
详细描述
Enrollment (day 0):
- Written consent
Post PTA (Day 1 ~3):
- Symptom: Rutherford class
- Adverse event
- Ankle-brachial index
- Laboratory test: - eGFR, Cr, ALT, AST
- Hb, WBC, platelet
- Concomitant medication
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 years of older
- •Symptomatic peripheral artery disease: Moderate or severe claudication (Rutherford category 2 or 3) and Critical limb ischemia (Rutherford category 4-5)
- •Femoropopliteal artery lesions with stenosis > 50%
- •ABI < 0.9 before treatment
- •Patents treated with ELUVIA stent for femoropopliteal artery disease
- •Patients with signed informed consent
排除标准
- •Acute critical limb ischemia
- •Severe critical limb ischemia (Rutherford category 6)
- •Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
- •In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment)
- •Bypass graft lesions
- •Age > 85 years
- •Severe hepatic dysfunction (> 3 times normal reference values)
- •Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- •LVEF < 40% or clinically overt congestive heart failure
- •Pregnant women or women with potential childbearing
- •Life expectancy <1 year due to comorbidity
- •Untreated proximal inflow disease of the ipsilateral iliac arteries (more than 50% stenosis or occlusion)
结局指标
主要结局
Primary patency
时间窗: at 12 months
Absence of stenosis \>50% by an follow-up imaging study (duplex ultrasound, CT or catheter-based angiography) at 12 months
次要结局
- Ruthford category(at 12 months)
- stent fracture rate(at 12 months)
- Ankle-brachial index(at 12 months)
- target lesion revascularization(at 12 months)
研究者
研究点 (1)
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