NCT04304105已完成不适用
Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 25
- 主要终点
- Amputation Free Survival (AFS)
研究概览
简要总结
The objective of this observational registry is to track the clinical progression of chronic limb-threatening ischemia (CLTI) and incidence of death, amputation, and revascularization attempts over a one-year period.
详细描述
The objective of this observational registry is to track the clinical progression of chronic limb-threatening ischemia (CLTI) and incidence of death, amputation, and revascularization attempts over a one-year period.
The study population is comprised of Rutherford 5 and 6 CLTI subjects who have hemodynamic evidence of severely diminished arterial inflow of a peripheral limb and:
- 2 revascularizations in the last 6 months that failed to resolve symptoms, OR
- have inadequate popliteal, tibial, or pedal revascularization target
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
- •Subject must be ≥18 years of age
- •Subject is Rutherford 5 or 6 classification with hemodynamic evidence of severely diminished arterial inflow of a peripheral limb and: a) 2 revascularizations in the last 6 months that failed to resolve symptoms, OR b) An inadequate popliteal, tibial, or pedal revascularization target
- •Subject is willing and able to sign the informed consent form and willing to participate in the phone follow-ups.
排除标准
- •Any significant concurrent psychological or social condition (e.g., no support person/network), which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator.
- •Subject is participating in the PROMISE II Clinical Trial.
结局指标
主要结局
Amputation Free Survival (AFS)
时间窗: 12 months
Defined as freedom from major (above ankle) amputation and death
次要结局
- Minor Amputation(12 months)
- Change in Rutherford Classification(6 months and 12 months)
研究者
研究点 (25)
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