NCT06234280已完成不适用
Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical 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 24 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
• Prospective, multi-center single-arm observational study
Screening (day 0):
- Medical history and demography of the patient reviewed
- Inclusion/exclusion eligibility will be checked
- Physical examination (Height, weight)
- Laboratory test
- BUN, eGFR, Cr.
- Hb, WBC, platelet
- Lipid level (total cholesterol, LDL-C, triglyceride, HDL-C)
- Ankle-brachial index
- Imaging study (CT/MR angiography, Doppler ultrasound, or catheter angiography)
- Medication
Enrollment (day 0):
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)
- •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
Clinical patency
时间窗: at 24 months
Freedom from symptom worsening, as indicated by an increase in Rutherford category accompanied by a ≥ 0.15 decrease in ABI or \> 50% restenosis on imaging studies at 24 months.
次要结局
- stent fracture rate(at 12 and 24 months)
- target lesion revascularization(at 12 and 24 months)
- Ankle-brachial index(at 12 and 24 months)
- Ruthford category(at 12 and 24 months)
研究者
研究点 (1)
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