Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

Peripheral Arterial Disease Clinical Trial

Official title:

Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01378260
• Other study ID #: 40153
• Secondary ID: R01HS2002501
• Status: Completed
• Phase: N/A
• First received: June 13, 2011
• Last updated: May 16, 2017
• Start date: July 2011
• Est. completion date: August 2015

Study information

• Verified date: May 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: August 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
United States	Lake Washington Vascular	Bellevue	Washington
United States	PeaceHealth St. Joseph Medical Center	Bellingham	Washington
United States	Providence Everett	Everett	Washington
United States	St. Francis Hospital	Federal Way	Washington
United States	Good Samaritan Hospital	Puyallup	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	Northwest Hospital and Medical Center	Seattle	Washington
United States	University of Washington	Seattle	Washington
United States	Providence Sacred Heart Medical Center	Spokane	Washington
United States	St. Joseph Medical Center	Tacoma	Washington
United States	Tacoma General Hospital	Tacoma	Washington
United States	PeaceHealth Southwest Medical Center - Thoracic & Vascular Surgery	Vancouver	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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