NCT07016698招募中不适用
A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)
C. R. Bard4 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年9月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- Procedural Success
研究概览
简要总结
The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.
详细描述
The study will recruit approximately 600 subjects treated for PAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or legally authorized representative provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the IRB for the site.
- •Subject is ≥22 years old at the time of signing the informed consent.
- •Subject must have a lesion(s) in their infra-inguinal peripheral arteries that can be treated with the RotarexTM Rotational Excisional Atherectomy System according to Instructions For Use (IFU).
- •Rutherford 2-5 for chronic limb ischemia and Rutherford I to IIb for acute limb ischemia.
- •Target lesion can be crossed intra-luminally by guidewire.
- •At least one patent native outflow artery to the foot, free from significant stenosis(≥50% stenosis as confirmed by angiography) (ChLI Cohort only, not applicable to ALI Cohort).
排除标准
- •Subject is unable or unwilling to comply with follow-up procedures and visits.
- •Subject has a target lesion in a vessel with less than 3 mm in diameter.
- •Subject is participating in another device or drug clinical trial that interferes with this protocol and confounds results.
- •Treatment plan includes use of a thrombectomy and/or atherectomy device other than RotarexTM Rotational Excisional Atherectomy System.
- •Life expectancy is below 1 year.
- •Pregnant, planning to become pregnant during the course of the study or nursing a child.
结局指标
主要结局
Procedural Success
时间窗: Immediate Post Index Procedure
Procedural Success defined as the rate of successful revascularization of target lesion (residual stenosis/thrombus ≤30%) following index procedure.
Freedom from major complications
时间窗: 30 days post index procedure
Freedom from composite of device and/or procedure related perioperative (≤30 day) death, unplanned target limb major amputation (above the ankle), and clinically driven target lesion revascularization (CD-TLR) at 30 days post index procedure
次要结局
未报告次要终点
研究者
研究点 (4)
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