Assessment of the Utility of the Pantheris SV System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Technical success
研究概览
简要总结
A single-arm study to assess the utility of the Pantheris SV catheter in addressing peripheral artery disease in arteries located below the knee. Data will be collected on the percent stenosis pre- and post-atherectomy and then symptoms and adverse events noted at 30 days, 6 months, and 1 year after the procedure.
详细描述
This is a post-market, single-arm study of the optical coherence tomography (OCT)-guided directional atherectomy catheter, Pantheris SV. Patients presenting with reduced blood flow in the lower extremity arteries will under directional atherectomy, followed by adjunctive therapy as deemed necessary by the physician, and then adverse events and symptom resolution will be documented at 30 days, 6 months, and 1 year after the procedure. Primary safety endpoints are related to adverse events and will be assessed at the time of the procedure and at 30 days after the procedure. Effectiveness endpoints center on restoration of blood flow.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Target lesion in the infragenicular segment
- •At least 1 pedal vessel noted in the foot
- •Rutherford classification 3 to 6
- •Willing to give informed consent
排除标准
- •if female, is pregnant or breast feeding
- •has had surgery or endovascular procedure within 30 days prior to the index procedure
- •has planned surgery within 30 days after the index procedure
- •had a major bleeding event within 60 days prior to the index procedure
- •currently in the treatment phase of a drug or device trial
- •has anticipated life span of less than 1.5 years
- •is unwilling to present to the investigator at 30 days, 6 moths, or 1 year after the index procedure
结局指标
主要结局
Technical success
时间窗: At 1 day post-procedure
defined as residual stenosis \< 50 percent after atherectomy
Major Adverse Events
时间窗: from procedure to 30 days post-procedure
freedom from cardiovascular-related events
次要结局
- Procedure success(At 1 day post-procedure)
- Freedom from target vessel revascularization (TVR)(At 6 and 12 months post-procedure)
- Primary patency(At 6 and 12 months post-procedure)
- Ankle-Brachial Index (ABI)(At 6 and 12 months post-procedure)
- Rutherford Classificaiton(At 30 days, 6 months, and 1 year post-procedure)