Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 12/17/2016 |
Start Date: | July 2011 |
End Date: | August 2015 |
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.
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.
Inclusion Criteria:
1. Diagnosis of claudication
2. 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)
Exclusion Criteria:
1. those with documented acute ischemia, rest pain or ulceration
2. those with claudication determined to be of aortic or iliac origin
3. those with claudication that is not caused by atherosclerotic disease
4. those without access to a telephone or Internet and are unwilling to participate in
surveys by mail at home (assess in patient screen)
5. those who otherwise refuse to participate (assessed in patient screen)
6. those who have a diagnosis of dementia confirmed in their medical record
7. those who are not English speaking
8. children and young adults up to and including age 20-years
We found this trial at
12
sites
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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St. Francis Hospital St. Francis Hospital, conveniently located near the center of Federal Way, serves...
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Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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