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Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

NCT01378260 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 323

Last updated 2017-05-18

No results posted yet for this study

Summary

The specific aim of this study is to prospectively compare outcomes (functional, quality of life, risk-adjusted clinical event) of medical management, surgical or endovascular (angioplasty or stent placement) interventions for the treatment of claudication caused by peripheral arterial disease. This study will test two major hypotheses;

Hypothesis 1: At 12-months, surgical interventions are associated with greater improvements in function, claudication symptoms, and health-related quality of life (HRQoL) than endovascular procedures or medical management.

Hypothesis 2: At 12-months, surgical and endovascular interventions are associated with greater improvements in function, claudication symptoms, and HRQoL than medical management.

Conditions

  • Peripheral Arterial Disease
  • Claudication

Sponsors & Collaborators

Principal Investigators

  • David R Flum, MD · University of Washington

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-09-30
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01378260 on ClinicalTrials.gov