Chronic Limb-Threatening Ischemia Treated With Intravascular Lithotripsy Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 86
- 主要终点
- Wound healing and freedom from amputation
研究概览
简要总结
CALCIO is a multicentre, prospective, observational cohort study that will collect real world data on the use of intravascular Lithotripsy (IVL) with the Shockwave IVL system to disrupt calcified femoropopliteal and crural lesions in patients with chronic limb-threatening ischemia (CLTI). The primary objective of CALCIO is to understand the effectiveness of IVL in promoting wound healing and preventing amputation. The secondary objectives of CALCIO are to evaluate the immediate effectiveness of the treatment in restoring vessel patency as well as its safety and impact on patients' quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient with chronic limb-threatening ischemia (Rutherford Category ≥4)
- •Femoropopliteal and/or crural calcified lesions visible on fluoroscopy;
- •Treatment with IVl using the Shockwave Medical IVL System.
排除标准
- •< 18 years old;
- •Incapacity or refusal to give informed consent;
- •Ongoing pregnancy;
- •Endovascular procedure(s) on the treatment site within 4 weeks before the planned IVL treatment.
研究组 & 干预措施
Full cohort
Intravascular lithotripsy of femoropopliteal and crural lesions as per standard of care
干预措施: Shockwave Medical IVL System (Device)
结局指标
主要结局
Wound healing and freedom from amputation
时间窗: 12 months
Composite of wound healing defined as the healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening) and freedom from amputation defined as the absence of any amputation of the treated limb: minor (digital, metatarsal), major below the knee or major above the knee (excluding any amputation planned before the IVL procedure).
次要结局
- Wound healing(24 months)
- Freedom from amputation(24 months)
- Amputation-free survival(through study completion, approximately 2 years)
- Change in Rutherford classification category(12 and 24 months)
- Change in foot ischemia(12 and 24 months)
- Change in WIfi score(12 and 24 months)
- Freedom from clinically-driven target lesion revascularization (CD-TLR)(12 and 24 months)
- CD-TLR-free survival(through study completion, approximately 2 years)
- Primary patency rate(12 and 24 months)
- Assisted primary patency rate(12 and 24 months)
- Secondary patency rate(12 and 24 months)
- Technical success of IVL(on the day of the procedure)
- Overall procedural success(on the day of the procedure)
- Frequency and severity of procedural complications and other adverse events(Within 30 days after the procedure)
- Patient-reported health-related quality-of-life(at 6, 12 and 24 months)
- Wound healing(24 months)
- Freedom from amputation(24 months)
- Amputation-free survival(through study completion, approximately 2 years)
- Change in Rutherford classification category(12 and 24 months)
- Change in foot ischemia(12 and 24 months)
- Change in WIfi score(12 and 24 months)
- Freedom from clinically-driven target lesion revascularization (CD-TLR)(12 and 24 months)
- CD-TLR-free survival(through study completion, approximately 2 years)
- Primary patency rate(12 and 24 months)
- Assisted primary patency rate(12 and 24 months)
- Secondary patency rate(12 and 24 months)
- Technical success of IVL(on the day of the procedure)
- Overall procedural success(on the day of the procedure)
- Frequency and severity of procedural complications and other adverse events(Within 30 days after the procedure)
- Patient-reported health-related quality-of-life(at 6, 12 and 24 months)