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OpenTrials
Completed

NCT Number: NCT01588067

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser Permanente Colorado, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change from baseline in Health Status at 6 months

    Time frame: Baseline (pre procedure), 6 months

    Health Status will be measured at baseline and six months following the procedure

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

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

Acronym: PAD

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 30, 2012
Registry last updated
Jul 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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