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Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01378260
First Posted: June 22, 2011
Last Update Posted: May 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Flum, University of Washington
June 13, 2011
June 22, 2011
May 18, 2017
July 2011
September 2014   (Final data collection date for primary outcome measure)
The primary outcome is the change in score on the Walking Impairment Questionnaire (WIQ) from the baseline assessment to the 12-month assessment. [ Time Frame: 12-Months Post-Index Date ]
The primary outcome of the study, and the outcome on which the study is powered, is the change in score on the WIQ from the baseline assessment to the 12-month assessment. There are three subscales within the WIQ; summary scores will be calculated separately for each - the walk distance, walk speed, stair climb.
Same as current
Complete list of historical versions of study NCT01378260 on ClinicalTrials.gov Archive Site
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Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)
Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
patients being seen by a physician with newly diagnosed or established claudication
  • Peripheral Arterial Disease
  • Claudication
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  • Surgical Bypass
    use of synthetic or endogenous (vein) or composite graft to treat lesions in the superficial femoral, common femoral, or popliteal artery
  • Endovascular Therapy
    angioplasty and/or stent to treat lesions in the superficial femoral or popliteal artery
  • Medical Management

    Documentation of the following in the medical record:

    i. Walking/physical therapy to improve endurance was recommended; ii. For tobacco users, tobacco cessation was recommended; iii. Prescribing pentoxifylline (Trental) or cilostazol (pletal) iv. Ongoing care by physician for treatment of claudication

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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
323
August 2015
September 2014   (Final data collection date for primary outcome measure)

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 to treat lesions in the superficial femoral, common femoral or popliteal artery)
    • Endovascular therapy (angioplasty and/or stent to treat lesions in the superficial femoral, common femoral or popliteal artery)
    • Medical management (i.e. smoking cessation, walking therapy, long-term monitoring by physician)

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 in surveys 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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01378260
40153
R01HS2002501
No
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David Flum, University of Washington
University of Washington
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Principal Investigator: David R Flum, MD University of Washington
University of Washington
May 2017