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

Kaiser Permanente271 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

271

Conditions

Peripheral Arterial Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

VA Eastern Colorado Health Care System

Denver, Colorado, United States

Kaiser Permanente Colorado

Denver, Colorado, United States

Outcomes

Primary Outcomes

Change from baseline in Health Status at 6 months

Health Status will be measured at baseline and six months following the procedure

Time frame: Baseline (pre procedure), 6 months

Data from ClinicalTrials.gov

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