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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

271 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Arterial Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Medical

Patients treated for PAD medically or with exercise therapy

No interventions assigned to this group

Endovascular

Patients with PAD treated with endovascular therapy

No interventions assigned to this group

Surgery

Patients with PAD treated with surgery

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No