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

Kaiser Permanente

Status: Completed

Conditions: Peripheral Arterial Disease

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01588067

CO-10-1488

Details and patient eligibility

About

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.

Full 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.

Enrollment: 271 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

271 participants in 3 patient groups

Medical

Description:

Patients treated for PAD medically or with exercise therapy

Endovascular

Description:

Patients with PAD treated with endovascular therapy

Surgery

Description:

Patients with PAD treated with surgery