Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

Completed

• Conditions: Claudication; Peripheral Arterial Disease

• Registration Number: NCT01378260
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-20
• Study First Posted: 2011-06-22
• Study Start: 2011-07
• Primary Completion: 2014-09
• Study Completion: 2015-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 323

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the change in score on the Walking Impairment Questionnaire (WIQ) from the baseline assessment to the 12-month assessment.	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.

Trial Locations

Locations (12)

University of Washington; 🇺🇸 Seattle, Washington, United States

Good Samaritan Hospital; 🇺🇸 Puyallup, Washington, United States

Providence Sacred Heart Medical Center; 🇺🇸 Spokane, Washington, United States

St. Francis Hospital; 🇺🇸 Federal Way, Washington, United States

St. Joseph Medical Center; 🇺🇸 Tacoma, Washington, United States

Providence Everett; 🇺🇸 Everett, Washington, United States

Lake Washington Vascular; 🇺🇸 Bellevue, Washington, United States

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

PeaceHealth St. Joseph Medical Center; 🇺🇸 Bellingham, Washington, United States

Tacoma General Hospital; 🇺🇸 Tacoma, Washington, United States

Northwest Hospital and Medical Center; 🇺🇸 Seattle, Washington, United States

PeaceHealth Southwest Medical Center - Thoracic & Vascular Surgery; 🇺🇸 Vancouver, Washington, United States