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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease

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 Type: Observational
• Enrollment (Actual): 271

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80220
      • VA Eastern Colorado Health Care System
    • Denver, Colorado, United States, 80231
      • Kaiser Permanente Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients with PAD

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Medical; Patients treated for PAD medically or with exercise therapy
Endovascular; Patients with PAD treated with endovascular therapy
Surgery; Patients with PAD treated with surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Health Status at 6 months	Health Status will be measured at baseline and six months following the procedure	Baseline (pre procedure), 6 months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: David Magid, MD, MPH, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: April 4, 2012
• First Submitted That Met QC Criteria: April 26, 2012
• First Posted (ESTIMATE): April 30, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 8, 2015
• Last Update Submitted That Met QC Criteria: July 6, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: CO-10-1488