Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

Conditions
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Peripheral Arterial Disease, Claudication

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical Bypass<br>use of synthetic or endogenous (vein) or composite graft to treat lesions in the superficial femoral, common femoral, or popliteal artery | |
| Endovascular Therapy<br>angioplasty and/or stent to treat lesions in the superficial femoral or popliteal artery | |
| Medical Management<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Disease, Claudication, Comparative Effectiveness Research, PAD Study, PAD, atherosclerosis, Intermittent claudication, leg pain