Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- Phoenix device performance
研究概览
简要总结
The Phoenix Post-Approval Registry is a prospective, multi-center, single arm registry sponsored by Volcano Corporation to evaluate the short and long term performance and clinical outcomes of the Phoenix Atherectomy System.
详细描述
The Phoenix Post-Approval Registry is an prospective, multi-center, single arm registry, sponsored by Volcano Corporation, to evaluate the short and long term performance and clinical outcomes of the Phoenix Atherectomy System. The study includes consecutive patients treated with the Phoenix Atherectomy System in a post-market (commercial device use) setting. Patients will be followed under real-world conditions for up to 12 months after the index procedure.
All patients with a planned endovascular revascularization procedure receiving treatment with the Phoenix Atherectomy System as all or part of their PAD treatment strategy may be included. Written informed consent must be obtained from each patient prior to enrollment in the study. Enrolled patients will undergo PAD treatment that includes Phoenix atherectomy, according to institutional or local standard of care. Data collection will include medical record review of procedures performed according to standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •The patient is ≥18 years of age.
- •Patient understands the research nature of the study and is willing and capable of providing written informed consent.
- •Scheduled for and receives treatment with the Phoenix Atherectomy System as all or part of their PAD treatment.
- •Meets Phoenix Atherectomy System catheter Instruction for Use (IFU) criteria.
排除标准
- •Patients who have ANY of the following exclusion criteria are NOT eligible for the study:
- •Patients unwilling or unable to comply with the protocol including 12-month follow-up for patients with CLI at baseline.
- •Patient is participating in another device or drug clinical trial that interferes with this protocol follow up schedule.
结局指标
主要结局
Phoenix device performance
时间窗: 30 days
Rates of TECHNICAL SUCCESS (ratio of Phoenix treated lesions with \<=50% residual diameter stenosis to all Phoenix treated lesions); and PROCEDURAL SUCCESS (ratio of target lesion residual stenosis of \<=30% after treatment with Phoenix and adjunctive treatments to all treated lesions)
次要结局
- Clinically-driven target lesion revascularization (TLR) in patients with CLI at baseline(12 months)
- Clinically-driven target vessel revascularization (TVR) in patients with CLI at baseline(12 months)
- Unplanned target limb amputation in patients with CLI at baseline(12 months)
- Society for Vascular Surgery's Wound, Ischemia, and foot Infection (WIfI) category(12 months)
- Rutherford Clinical Category(12 months)
- Ankle brachial index (ABI)(12 months)