Efficacy of Self-Expanding Nitinol Stent Versus Balloon Angioplasty Alone for the Below The Knee Arteries Following Successful Balloon Angioplasty Trial (Korean Vascular Intervention Multicenter Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Angiographic binary restenosis rate
研究概览
简要总结
The objectives of this study are to compare directly conventional balloon angioplasty alone versus. balloon angioplasty with routine stenting - that is, to determine whether angioplasty with self-expanding stent is superior to conventional balloon angioplasty - in the infrapopliteal arterial occlusive lesions of critical limb ischemia patients by collecting and analyzing the cases of each patient group in a prospective multicenter randomized clinical trial, and to clarify main factors affecting mid- and long-term clinical effects of angioplasty with self-expanding stent in the infrapopliteal arteries.
Hypothesis: Balloon PTA followed by routine stenting with self-expanding nitinol stent in critical limb ischemia patients with infrapopliteal arterial occlusive lesions is superior to conventional PTA in the aspect of vascular restenosis rate.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic critical limb ischemia (Rutherford 4 - 6)
- •Patients with signed informed consent
- •Target lesion length < 8 cm by angiographic estimation
- •Stenosis of >50% or occlusive atherosclerotic lesion of the ipsilateral infrapopliteal artery
- •Reference vessel diameter should be 2.0-4.5 mm
排除标准
- •Patient has a known allergy to heparin, aspirin, or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies
- •Patient takes warfarin
- •Patient has a history of previous life-threatening contrast media reaction
- •Patient is currently enrolled in another investigational device or drug trial
- •Patient is currently breast-feeding, is pregnant, or intends to become pregnant
- •Patient is mentally ill or retarded
- •Acute critical limb ischemia
- •Major bleeding history within prior 2 months
- •Severe hepatic dysfunction (> 3 times normal reference values)
- •Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- •Life expectancy <1 year due to comorbidity
- •Reference segment diameter is not suitable for available stent design
- •Previously implanted stent(s) or PTA at the same lesion site
- •Inflow-limiting arterial lesions left untreated
研究组 & 干预措施
Primary stenting
A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty
干预措施: self-expanding nitinol stent (Device)
Balloon only
A group of patients who will undergo routine conventional balloon angioplasty alone without stenting
干预措施: balloon angioplasty (Device)
结局指标
主要结局
Angiographic binary restenosis rate
时间窗: 12 months
次要结局
未报告次要终点
研究者
Seung Woon Rha
Professor
Korea University Guro Hospital