Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 271
- 试验地点
- 2
- 主要终点
- Change from baseline in Health Status at 6 months
研究概览
简要总结
This study is designed to develop a clinical registry of Peripheral Arterial Disease (PAD) patients undergoing lower extremity revascularization to describe the population and assess comparative effectiveness of endovascular therapy versus surgery. In addition, this study will conduct a prospective cohort study of patients treated medically or undergoing lower extremity revascularization at the VA and Kaiser Colorado to compare changes in health status.
详细描述
Using electronic medical records, a registry of patients undergoing lower extremity revascularization therapy will be identified. Chart reviews with be done by an expert panel.
The prospective cohort study will ask participants to complete health status surveys before they begin therapy for PAD and again 6 months later.
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
- •presents with PAD,
- •> 18 years of age,
- •can complete a questionnaire, and
- •has either had a change in PAD lower extremity intervention or start of a new intervention (surgical, endovascular, or medical therapy (cilostazol or exercise regimen)
排除标准
- •dementia,
- •inability to consent,
- •pregnancy,
- •limited life expectancy (< 6 months),
- •previous endovascular or surgical revascularization within the previous 12 months,
- •non English speaking
结局指标
主要结局
Change from baseline in Health Status at 6 months
时间窗: Baseline (pre procedure), 6 months
Health Status will be measured at baseline and six months following the procedure
次要结局
未报告次要终点