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

Completed

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT01588067
• Lead Sponsor: Kaiser Permanente

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-26
• Study First Posted: 2012-04-30
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-06
• Last Update Posted: 2015-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in Health Status at 6 months	Baseline (pre procedure), 6 months	Health Status will be measured at baseline and six months following the procedure

Trial Locations

Locations (2)

Kaiser Permanente Colorado; 🇺🇸 Denver, Colorado, United States

VA Eastern Colorado Health Care System; 🇺🇸 Denver, Colorado, United States