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| ID | Type | Description | Link |
|---|---|---|---|
| R01HS2002501 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 or popliteal artery | ||
| Medical Management | Documentation of the following in the medical record: i. Walking/physical therapy to improve endurance was recommended; ii. For tobacco users, tobacco cessation was recommended; iii. Prescribing pentoxifylline (Trental) or cilostazol (pletal) iv. Ongoing care by physician for treatment of claudication |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-Months Post-Index Date |
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Inclusion Criteria:
Diagnosis of claudication
Be undergoing one of three treatments for claudication:
Exclusion Criteria:
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patients being seen by a physician with newly diagnosed or established claudication
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| Name | Affiliation | Role |
|---|---|---|
| David R Flum, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lake Washington Vascular | Bellevue | Washington | 98004 | United States | ||
| PeaceHealth St. Joseph Medical Center |
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| Bellingham |
| Washington |
| 98225 |
| United States |
| Providence Everett | Everett | Washington | 98201 | United States |
| St. Francis Hospital | Federal Way | Washington | 98003 | United States |
| Good Samaritan Hospital | Puyallup | Washington | 98372 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Northwest Hospital and Medical Center | Seattle | Washington | 98133 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Providence Sacred Heart Medical Center | Spokane | Washington | 99204 | United States |
| St. Joseph Medical Center | Tacoma | Washington | 98405 | United States |
| Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| PeaceHealth Southwest Medical Center - Thoracic & Vascular Surgery | Vancouver | Washington | 98664 | United States |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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