Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

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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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Claudication Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lake Washington Vascular, Bellevue, Washington, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2015
First posted: Jun 22, 2011
Registry last updated: May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed