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.
Study Type
OBSERVATIONAL
Enrollment
323
Lake Washington Vascular
Bellevue, Washington, United States
PeaceHealth St. Joseph Medical Center
Bellingham, Washington, United States
Providence Everett
Everett, Washington, United States
St. Francis Hospital
Federal Way, Washington, United States
Good Samaritan Hospital
Puyallup, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Northwest Hospital and Medical Center
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Providence Sacred Heart Medical Center
Spokane, Washington, United States
St. Joseph Medical Center
Tacoma, Washington, United States
...and 2 more locations
The primary outcome is the change in score on the Walking Impairment Questionnaire (WIQ) from the baseline assessment to the 12-month assessment.
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.
Time frame: 12-Months Post-Index Date
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