Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)
2 other identifiers
observational
323
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2011
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2011
CompletedFirst Posted
Study publicly available on registry
June 22, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedMay 18, 2017
May 1, 2017
3.2 years
June 13, 2011
May 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
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
Eligibility Criteria
patients being seen by a physician with newly diagnosed or established claudication
You may qualify if:
- Diagnosis of claudication
- 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)
You may not qualify if:
- those with documented acute ischemia, rest pain or ulceration
- those with claudication determined to be of aortic or iliac origin
- those with claudication that is not caused by atherosclerotic disease
- those without access to a telephone or Internet and are unwilling to participate in surveys by mail at home (assess in patient screen)
- those who otherwise refuse to participate (assessed in patient screen)
- those who have a diagnosis of dementia confirmed in their medical record
- those who are not English speaking
- children and young adults up to and including age 20-years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Lake Washington Vascular
Bellevue, Washington, 98004, United States
PeaceHealth St. Joseph Medical Center
Bellingham, Washington, 98225, United States
Providence Everett
Everett, Washington, 98201, United States
St. Francis Hospital
Federal Way, Washington, 98003, United States
Good Samaritan Hospital
Puyallup, Washington, 98372, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Northwest Hospital and Medical Center
Seattle, Washington, 98133, United States
University of Washington
Seattle, Washington, 98195, United States
Providence Sacred Heart Medical Center
Spokane, Washington, 99204, United States
St. Joseph Medical Center
Tacoma, Washington, 98405, United States
Tacoma General Hospital
Tacoma, Washington, 98405, United States
PeaceHealth Southwest Medical Center - Thoracic & Vascular Surgery
Vancouver, Washington, 98664, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David R Flum, MD
University of Washington
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 13, 2011
First Posted
June 22, 2011
Study Start
July 1, 2011
Primary Completion
September 1, 2014
Study Completion
August 1, 2015
Last Updated
May 18, 2017
Record last verified: 2017-05