Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial Disease



Status:Completed
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2011
End Date:September 2014

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Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial Disease.

This study is designed to develop a clinical registry of Peripheral Arterial Disease (PAD)
patients undergoing lower extremity revascularization to describe the population and assess
comparative effectiveness of endovascular therapy versus surgery. In addition, this study
will conduct a prospective cohort study of patients treated medically or undergoing lower
extremity revascularization at the VA and Kaiser Colorado to compare changes in health
status.

Using electronic medical records, a registry of patients undergoing lower extremity
revascularization therapy will be identified. Chart reviews with be done by an expert panel.

The prospective cohort study will ask participants to complete health status surveys before
they begin therapy for PAD and again 6 months later.

Inclusion Criteria:

- presents with PAD,

- > 18 years of age,

- can complete a questionnaire, and

- has either had a change in PAD lower extremity intervention or start of a new
intervention (surgical, endovascular, or medical therapy (cilostazol or exercise
regimen)

Exclusion Criteria:

- dementia,

- inability to consent,

- pregnancy,

- limited life expectancy (< 6 months),

- previous endovascular or surgical revascularization within the previous 12 months,

- non English speaking
We found this trial at
2
sites
Denver, Colorado 80205
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