Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 6
- 主要终点
- Primary Patency
研究概览
简要总结
This study will test whether using ultrasound imaging within blood vessels during minimally invasive treatment of leg arteries in patients with peripheral artery disease leads to better clinical outcomes.
详细描述
This is a U.S. prospective multicenter randomized controlled trial to evaluate the clinical outcomes of Intravascular ultrasound (IVUS) guided Lower Extremity (LE) endovascular intervention in patients with symptomatic peripheral artery disease (PAD) (Rutherford class 2-5).
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
- Single (Participant)
盲法说明
Single-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Symptomatic LE PAD - Rutherford Class 2-5
- •Angiographic evidence of >50% stenosis
- •Undergoing LE peripheral artery intervention
- •Target lesion is iliac, femoropopliteal, profunda or supramalleolar below-the-knee arteries (target lesions extending into the abdominal aorta and inframalleolar BTK may be included).
排除标准
- •Prior intervention at the target lesion within 6 months
- •Target lesion is abdominal aorta or inframalleolar BTK arteries
研究组 & 干预措施
Non-Intravascular Ultrasound (IVUS)
Intravascular Ultrasound (IVUS) is not used in the treatment of the target lesion.
干预措施: Angiographic-guided Intervention (Device)
Intravascular Ultrasound (IVUS)
Intravascular Ultrasound (IVUS) is used during the treatment of the target lesion.
干预措施: Intravascular Ultrasound (IVUS) (Device)
结局指标
主要结局
Primary Patency
时间窗: From enrollment to 6 months
Freedom from restenosis ≥50% or an increase in Duplex Ultrasound peak systolic velocity ≥2.5 times reference proximal segment or target lesion revascularization (TLR).
次要结局
- Technical Success(Collected from index procedure)
- Procedural Success(Collected from Index procedure)
- Clinically driven-TLR (CD-TLR)(From enrollment to 12 months)
- Amputation-free Survival(From enrollment to 12 months)
- Functional Status Improvement (Vascular Quality of Life Questionnaire (VascuQoL-6))(From enrollment to 12 months)
- Functional Status Improvement (Rutherford Class Improvement)(From enrollment to 12 months)
- Cost Effectiveness(Evaluated at 12 months)