Understanding the Mechanism of Peripheral Arterial Balloon Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Luminal Gain
研究概览
简要总结
The purpose of this study is to compare the Chocolate PTA Balloon to standard Percutaneous Transluminal Angioplasty (PTA) catheters. The investigators will use Optical Coherence Tomography (OCT) and Quantitative Vascular Angiography to evaluate the acute vascular response of vessels treated with the Chocolate Balloon to a standard balloon catheter, with the primary endpoint being luminal gain assessed by OCT lumen volume measurements.
详细描述
Subjects will be randomized to treatment with either the Chocolate Balloon catheter or a standard balloon angioplasty catheter. All angioplasty procedures will be conducted with treatment balloon at the full discretion of the physician and according to the standard practice at the hospital and the device Instructions for Use. All patients will undergo baseline OCT imaging in addition to standard angiography. Post-PTA, all patients will then undergo repeat OCT imaging immediately post-procedure and then again at 10-minutes post-procedure to assess for vascular recoil.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reference Vessel Diameter (RVD) between 2.5 and 6.0mm and within treatment range of available balloon at Target Lesion
- •Intermittent claudication or critical limb ischemia (Rutherford 3-5)
- •De novo stenosis (≥70%) or occlusion in the infrainguinal arteries, including superficial femoral artery (SFA), popliteal, and infrapopliteal arteries.
- •Lesion successfully crossed with a guide-wire
- •Patient has given informed consent to participate in this study
排除标准
- •Lesion requiring ablative procedures (i.e. atherectomy or laser) as part of treatment
- •Lesion length >75mm
- •Previous bypass or stent at target vessel or proximal to target vessel
- •Significant in-flow disease at target lesion
- •Known inadequate distal outflow disease or planned treatment of vessel distal to target lesion
- •Acute limb ischemia or need for thrombolytic therapy
- •Known intolerance to required study medications, contrast media, or nitinol
- •Known impaired Renal Function with Glomerular Filtration Rate (GFR) <45 ml/min per 1.73m2
- •Known bleeding disorder or uncontrolled hypercoagulable disorder.
结局指标
主要结局
Luminal Gain
时间窗: Average of 90 minutes
Luminal Gain as defined by OCT lumen volume measurements. Luminal gain is assessed as the percentage change comparing pre-treatment and post-treatment volume measurements in cubic centimeters (CC) or millimeters (m3).
次要结局
- Optimal PTA(Average of 90 minutes)
- Dissection(Average of 90 minutes)
- Hematoma(Average of 90 minutes)