Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

Completed

Conditions studied: Peripheral Arterial Disease, Claudication

In brief

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.

Key facts

Study ID

NCT01378260

Run by

University of Washington

People needed

323

Starts

2011-07-01

Expected to finish

2015-08-01

Last updated by the study team

2017-05-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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
• Tacoma General Hospital — Tacoma, Washington, United States
• PeaceHealth Southwest Medical Center - Thoracic & Vascular Surgery — Vancouver, Washington, United States

Full record on ClinicalTrials.gov

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