NCT03517904已完成不适用
Comparison of Intravascular Ultrasound-Guided vs. Angiography-guided Angioplasty and Dual-antiplatelet v. Triple-antiplatelet Therapy for Outcomes of Drug-coated Balloon in the Treatment of Femoropopliteal Artery Disease (IVUS-DCB)
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
- 237
- 试验地点
- 1
- 主要终点
- Procedures lesion stenosis degree
研究概览
简要总结
- Prospective, randomized, controlled, multi-center study
- A total of 240 subjects with femoropopliteal artery disease will be included according to inclusion and exclusion criteria.
- Patients will be randomized in a 1:1 manner into IVUS-guided or angiography-guided intervention group.
- Second 1:1 randomization into dual antiplatelet therapy (aspirin + clopidogrel) or triple antiplatelet therapy (aspirin + clopidogrel + cilostazol) is optional
- All patients will be treated with drug-coated balloons (In.PACT Admiral) for femoropopliteal lesions.
- Bare metal self-expandable stents will be used in addition according to findings of IVUS or angiography such as severity of arterial dissection or residual stenosis.
- Patients will be followed clinically for 1 year after the procedure.
- Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.
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
- None
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 or older
- •Symptomatic peripheral artery disease:
- •Moderate or severe claudication (Rutherford category 2 or 3)
- •Critical limb ischemia (Rutherford category 4 or 5)
- •Femoropopliteal artery disease (stenosis > 50%)
- •ABI <0.9
- •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
- •Patients requiring oral anticoagulation using warfarin or NOAC
- •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
- •Previous bypass surgery or stenting in the target femoropopliteal artery
- •Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)
研究组 & 干预措施
IVUS-guided group
Experimental
Intravascular ultrasound-guided intervention group
干预措施: IVUS-guided angioplasty (Procedure)
Angiography-guided group
Active Comparator
Angiography-guided intervention group
干预措施: Angiography-guided angioplasty (Procedure)
结局指标
主要结局
Procedures lesion stenosis degree
时间窗: at 12 months
Absence of restenosis \>50% by Duplex ultrasound, CT angiography, or catheter-based angiography
次要结局
- Survival free from target vessel revascularization(12 months)
研究者
研究点 (1)
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