Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

Status:	Completed
Conditions:	Peripheral Vascular Disease, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	21 - Any
Updated:	12/17/2016
Start Date:	July 2011
End Date:	August 2015

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.

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

We found this trial at

sites

Tacoma General Hospital

Tacoma, Washington 98415

from

Tacoma, WA