An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- Primary Patency
研究概览
简要总结
Non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the MicroStent™ System.
详细描述
Subjects with peripheral arterial disease (PAD) whom the investigator has treated or intends to treat with the MicroStent™ System per the current instructions for use (IFU), and who have given written informed consent, will be enrolled in this study. Up to 300 subjects will be enrolled:
The objective of this post market registry is to evaluate procedural and long-term clinical outcomes for subjects undergoing intervention with the MicroStent® System for treatment of lower extremity peripheral arterial disease (PAD), presenting with below-the-knee lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Any subject with below the knee, at the ankle level or below the ankle peripheral arterial lesions previously treated or intended to be treated with the MicroStent® System per the current indications for use
- •For across the ankle joint intervention, distal runoff to digital branches or arcuate arteries must be present on angiography prior to MicroStent deployment
- •Subject's age is ≥ 18 years.
- •Subject must be willing to sign a patient informed consent form.
排除标准
- •Subject is pregnant or planning to become pregnant during the study duration
- •Subject has a life expectancy of less than one (1) year
- •Subject has a known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications
- •Subject is enrolled in another study that has not reached its primary endpoint at the time of enrollment.
结局指标
主要结局
Primary Patency
时间窗: 6 months post-procedure
Freedom from target lesion occlusion with no clinically driven target lesion revascularization (TLR)
Freedom from Perioperative Death and Major Adverse Limb Events (MALE)
时间窗: 30 days post-procedure
Freedom from all-cause death or major adverse limb events. Major adverse limb events include above-ankle amputation, new bypass graft or graft revision, and thrombectomy or thrombolysis involving the target lesion.
次要结局
- Freedom from Major Amputation(6, 12, 24 Months)
- Device Success(Procedure)
- Technical Success(Procedure)
- Freedom from Major Adverse Limb Events(6, 12, 24 Months)
- Freedom from Clinically Driven Target Lesion Revascularization (TLR)(6, 12, 24 Months)
- Wound Healing(30 days, 6, 12, 24 Months)