NCT05551780招募中不适用
Treatment of Calcific Total Occlusions in Peripheral Artery Disease
SoundBite Medical Solutions, Inc.8 个研究点 分布在 3 个国家目标入组 130 人开始时间: 2023年2月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 8
- 主要终点
- Device Performance
研究概览
简要总结
Prospective, multi-center, non-randomized, open label, clinical study intended to provide data to demonstrate safety and performance of the SoundBite Crossing System XS Peripheral.
详细描述
The CaTO-PAD study includes a below-the-knee (BTK) sub-study (CaTO-BTK)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Scheduled for interventional treatment of de-novo lesion(s) of the following native arteries:
- •CaTO-PAD: infrainguinal
- •CaTO-BTK: infrapopliteal
- •Have at least one chronic total occlusion (CTO) with no flow observed in the distal lesion except the flow from collateral circulation
- •Presenting with the following:
- •CaTO-PAD: claudication or CLI (Rutherford Clinical Category 2-5) of the target limb
- •CaTO-BTK Sub-Study: - Category 4 or 5 only for CaTO-BTK Sub-Study CaTO-PAD: claudication or CLI (Rutherford Clinical Category 2-5) of the target limb
- •Age of > 18 years
- •Have been informed of the nature of the study, agrees to participate, and has signed the approved study consent form
- •Target lesion calcification is at least moderate by PARC definition (see Section 15)
- •Target lesion is refractory as demonstrated by a failed attempt with a guidewire
排除标准
- •Any medical condition that would make subject an inappropriate candidate for interventional treatment as determined by the Investigator, including the following:
- •Glomerular filtration rate <30 ml/min
- •Mortality expected within 30 days
- •Already enrolled in an investigational interventional study that would interfere with study endpoints
- •Target lesion is crossed intraluminally with a conventional guidewire
- •Treatment of an inflow lesion prior to target lesion treatment results in no reflow, thrombus formation, abrupt closure, distal embolization, dissection or perforation requiring treatment
- •Women who are pregnant or breastfeeding
结局指标
主要结局
Device Performance
时间窗: Day 0
Crossing of the lesion regardless of method or modality (e.g., antegrade or retrograde)
Device Safety
时间窗: Day 0
Procedural incidence of any of the following: no reflow, thrombus formation, abrupt closure, distal embolization, dissection or perforation requiring treatment
次要结局
- Residual Percent Stenosis(Day 0)
- Number of Devices Used(Day 0)
- CTO Crossing Time(Day 0)
- Fluoroscopy Time(Day 0)
- Secondary Safety Endpoint(Day 30 (+10/-0 days))
- Antegrade Crossing(Day 0)
- Procedure Time(Day 0)
- Acute Lumen Gain(Day 0)
研究者
研究点 (8)
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