Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 12
- 主要终点
- The primary outcome is the change in score on the Walking Impairment Questionnaire (WIQ) from the baseline assessment to the 12-month assessment.
研究概览
简要总结
The specific aim of this study is to prospectively compare outcomes (functional, quality of life, risk-adjusted clinical event) of medical management, surgical or endovascular (angioplasty or stent placement) interventions for the treatment of claudication caused by peripheral arterial disease. This study will test two major hypotheses;
Hypothesis 1: At 12-months, surgical interventions are associated with greater improvements in function, claudication symptoms, and health-related quality of life (HRQoL) than endovascular procedures or medical management.
Hypothesis 2: At 12-months, surgical and endovascular interventions are associated with greater improvements in function, claudication symptoms, and HRQoL than medical management.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of claudication
- •Be undergoing one of three treatments for claudication:
- •Surgical bypass (use of synthetic or endogenous (vein) or composite graft to treat lesions in the superficial femoral, common femoral or popliteal artery)
- •Endovascular therapy (angioplasty and/or stent to treat lesions in the superficial femoral, common femoral or popliteal artery)
- •Medical management (i.e. smoking cessation, walking therapy, long-term monitoring by physician)
排除标准
- •those with documented acute ischemia, rest pain or ulceration
- •those with claudication determined to be of aortic or iliac origin
- •those with claudication that is not caused by atherosclerotic disease
- •those without access to a telephone or Internet and are unwilling to participate in surveys by mail at home (assess in patient screen)
- •those who otherwise refuse to participate (assessed in patient screen)
- •those who have a diagnosis of dementia confirmed in their medical record
- •those who are not English speaking
- •children and young adults up to and including age 20-years
结局指标
主要结局
The primary outcome is the change in score on the Walking Impairment Questionnaire (WIQ) from the baseline assessment to the 12-month assessment.
时间窗: 12-Months Post-Index Date
The primary outcome of the study, and the outcome on which the study is powered, is the change in score on the WIQ from the baseline assessment to the 12-month assessment. There are three subscales within the WIQ; summary scores will be calculated separately for each - the walk distance, walk speed, stair climb.
次要结局
未报告次要终点
研究者
David Flum
Professor
University of Washington