Serranator OCT: Understanding the Mechanism of Action of Serration Angioplasty by Serranator Versus Conventional Balloon Angioplasty for below-the Knee (BTK) Artery Disease Using Optical Coherence Tomography (OCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Residual Lumen Volume Stenosis
研究概览
简要总结
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rutherford clinical category 4-6 of the target limb
- •Age of subjects is >18 years old
- •Patients has given informed consent to participate in this study
排除标准
- •De novo or restenotic (without prior stent) stenosis (≥70%) or occlusion
- •Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries.
- •Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm.
- •Lesion length less than 220 mm
研究组 & 干预措施
Serrantor
Subjects randomized to the Serranator Arm of the study will be treated with the Serranator PTA Serration Balloon
干预措施: Serranator PTA Serration Catheter (Device)
PTA
Subjects randomized to the PTA Arm of the study will be treated with a standard of care percutaneous transluminal angioplasty (PTA) balloon.
干预措施: PTA (Standard of Care) (Drug)
结局指标
主要结局
Residual Lumen Volume Stenosis
时间窗: Baseline
Residual lumen volume stenosis derived by OCT comparing Serration Angioplasty and conventional plain balloon angioplasty (PTA) measured at 10-15min post procedure. The lesion segment is defined as the entire treated segment where the balloon has been inflated.
次要结局
- OCT Residual Diameter Stenosis(Baseline)
- Angiography Residual Diameter Stenosis(Baseline)
- Dissection Pattern(Baseline)
- Correlation of Luminal Gain and Plaque Modification(Baseline)
- Rate of Optimal PTA(Baseline)
- Bail-out Stenting(Baseline)