Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)
This trial has been completed.
|Conditions||peripheral arterial disease, claudication|
|Sponsor||University of Washington|
|Start date||July 2011|
|End date||September 2014|
|Trial size||323 participants|
|Trial identifier||NCT01378260, 40153-D, R01HS2002501|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Bellevue, WA||Lake Washington Vascular||completed|
|Bellingham, WA||PeaceHealth St. Joseph Medical Center||completed|
|Everett, WA||Providence Everett||completed|
|Federal Way, WA||St. Francis Hospital||completed|
|Puyallup, WA||Good Samaritan Hospital||completed|
|Seattle, WA||Harborview Medical Center||completed|
|Seattle, WA||Northwest Hospital and Medical Center||completed|
|Seattle, WA||University of Washington||completed|
|Spokane, WA||Providence Sacred Heart Medical Center||completed|
|Tacoma, WA||St. Joseph Medical Center||completed|
|Tacoma, WA||Tacoma General Hospital||completed|
|Vancouver, WA||PeaceHealth Southwest Medical Center - Thoracic & Vascular Surgery||completed|
The primary outcome is the change in score on the Walking Impairment Questionnaire (WIQ) from the baseline assessment to the 12-month assessment.
time frame: 12-Months Post-Index Date
Male or female participants at least 21 years old.
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
|Official title||Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)|
|Principal investigator||David R Flum, MD|
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