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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01588067

Acronym

PAD

Enrollment

271

Registered

2012-04-30

Start date

2011-05-31

Completion date

2014-09-30

Last updated

2015-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results