Shockwave: Disruption for A Better Fit
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Major adverse cardiac events
研究概览
简要总结
Recent clinical trial results demonstrate that IVL can increase lumen area by emitting sonic pressure waves, with less inflation pressure as compared to traditional angioplasty balloon dilation and resulting in minimal trauma to the vessel. Therefore, the use of IVL prior to placement of a stent for severely calcified femoral popliteal arteries may be associated with more successful stent implants and better long-term patency, resulting in a decrease in cardiovascular events. The investigator will evaluate the success by defining as lesion stenosis less than 30% and no evidence of Major Adverse Cardiac Event including death or any amputation of the index limb within 30 days of the procedure.
详细描述
The purpose of this study is to evaluate the immediate and long term effectiveness of using intravenous lithotripsy followed by the placement of a Supera stent for the treatment of calcified femoral popliteal arteries. The use of IVL and Supera stent will be predetermined by the investigator according to inclusion criteria and the need for treatment and stenting combined, will be confirmed through the use of intravascular ultrasound and the investigators judgment for best practice. Following enrollment and index procedure, the subject will be followed prospectively for one year.
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
- •age ≥ 18 years
- •Treatment for de novo, densely calcified femoral popliteal arteries with 70-100% stenosis as measured by IVUS.
- •Lesion lengths up to 140 mm.
- •Planned follow-up within the health clinic.
排除标准
- •Calcified femoral popliteal arteries that show <70% stenosis by angiography.
- •Calcified femoral popliteal arteries with 100% stenosis in which the lesion cannot be crossed after pre-dilation with a 2-3mm balloon.
- •Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension).
- •Thrombophlebitis or deep venous thrombus, within the previous 30 days.
- •Evidence of end stage renal disease (ESRD) or stage 5 chronic kidney disease (CKD).
- •Currently receiving treatment in an investigational device or drug study or anticipate participating in an investigational device or drug study for the duration of this study.
- •Anticipated life expectancy less than 6 months.
- •Lack of phone or email for contact.
结局指标
主要结局
Major adverse cardiac events
时间窗: up to 30 days
a composite of Major Adverse Cardiac events (MACE) including death and any amputation of the index limb within 30 days. Study success will be defined as those patients who meet both the effectiveness and safety objectives.
Effectiveness
时间窗: immediately after the intervention
determining effectiveness of the procedure will be defined as final residual stenosis of \<30% post-stent placement, as measured by IVUS.
次要结局
- Patency of index vessel(up to 6 months)
- improved ankle-brachial index(1 year)
- Extended patency of index vessel(1 year)
- increase in minimum lumen area(immediately following intervention)