Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial Disease.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Kaiser Permanente
- Enrollment
- 271
- Locations
- 2
- Primary Endpoint
- Change from baseline in Health Status at 6 months
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change from baseline in Health Status at 6 months
Time Frame: Baseline (pre procedure), 6 months
Health Status will be measured at baseline and six months following the procedure