Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

Last updated: May 16, 2017
Sponsor: University of Washington
Overall Status: Completed

Phase

N/A

Condition

Peripheral Arterial Occlusive Disease

Claudication

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT01378260
40153
R01HS2002501
  • Ages > 21
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of claudication

  2. Be undergoing one of three treatments for claudication:

  • Surgical bypass (use of synthetic or endogenous (vein) or composite graft totreat lesions in the superficial femoral, common femoral or popliteal artery)

  • Endovascular therapy (angioplasty and/or stent to treat lesions in thesuperficial femoral, common femoral or popliteal artery)

  • Medical management (i.e. smoking cessation, walking therapy, long-term monitoringby physician)

Exclusion

Exclusion Criteria:

  1. those with documented acute ischemia, rest pain or ulceration

  2. those with claudication determined to be of aortic or iliac origin

  3. those with claudication that is not caused by atherosclerotic disease

  4. those without access to a telephone or Internet and are unwilling to participate insurveys by mail at home (assess in patient screen)

  5. those who otherwise refuse to participate (assessed in patient screen)

  6. those who have a diagnosis of dementia confirmed in their medical record

  7. those who are not English speaking

  8. children and young adults up to and including age 20-years

Study Design

Total Participants: 323
Study Start date:
July 01, 2011
Estimated Completion Date:
August 31, 2015

Connect with a study center

  • Grays Harbor Community Hospital

    Aberdeen, Washington 98520
    United States

    Site Not Available

  • Lake Washington Vascular

    Bellevue, Washington 98004
    United States

    Site Not Available

  • PeaceHealth St. Joseph Medical Center

    Bellingham, Washington 98225
    United States

    Site Not Available

  • Providence Everett

    Everett, Washington 98201
    United States

    Site Not Available

  • St. Francis Hospital

    Federal Way, Washington 98003
    United States

    Site Not Available

  • Good Samaritan Hospital

    Puyallup, Washington 98372
    United States

    Site Not Available

  • Harborview Medical Center

    Seattle, Washington 98104
    United States

    Site Not Available

  • Northwest Hospital and Medical Center

    Seattle, Washington 98133
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

  • Providence Sacred Heart Medical Center

    Spokane, Washington 99204
    United States

    Site Not Available

  • St. Joseph Medical Center

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Tacoma General Hospital

    Tacoma, Washington 98405
    United States

    Site Not Available

  • PeaceHealth Southwest Medical Center - Thoracic & Vascular Surgery

    Vancouver, Washington 98664
    United States

    Site Not Available

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