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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Claudication

• Study Type: Observational
• Enrollment (Actual): 323

Contacts and Locations

Study Locations

• United States
  • Washington
    • Bellevue, Washington, United States, 98004
      • Lake Washington Vascular
    • Bellingham, Washington, United States, 98225
      • PeaceHealth St. Joseph Medical Center
    • Everett, Washington, United States, 98201
      • Providence Everett
    • Federal Way, Washington, United States, 98003
      • St. Francis Hospital
    • Puyallup, Washington, United States, 98372
      • Good Samaritan Hospital
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center
    • Seattle, Washington, United States, 98195
      • University of Washington
    • Seattle, Washington, United States, 98133
      • Northwest Hospital and Medical Center
    • Spokane, Washington, United States, 99204
      • Providence Sacred Heart Medical Center
    • Tacoma, Washington, United States, 98405
      • Tacoma General Hospital
    • Tacoma, Washington, United States, 98405
      • St. Joseph Medical Center
    • Vancouver, Washington, United States, 98664
      • PeaceHealth Southwest Medical Center - Thoracic & Vascular Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients being seen by a physician with newly diagnosed or established claudication

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome is the change in score on the Walking Impairment Questionnaire (WIQ) from the baseline assessment to the 12-month assessment.	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.	12-Months Post-Index Date

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: David R Flum, MD, University of Washington

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: June 13, 2011
• First Submitted That Met QC Criteria: June 20, 2011
• First Posted (Estimate): June 22, 2011

Study Record Updates

• Last Update Posted (Actual): May 18, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: PAD; Claudication; atherosclerosis; leg pain; Peripheral Arterial Disease; Comparative Effectiveness Research; Intermittent claudication; PAD Study
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: 40153; R01HS2002501