Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

University of Washington

Status: Completed

Conditions: Claudication; Peripheral Arterial Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01378260

R01HS2002501

40153

Details and patient eligibility

About

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.

Enrollment: 323 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

323 participants in 3 patient groups

Surgical Bypass

Description:

use of synthetic or endogenous (vein) or composite graft to treat lesions in the superficial femoral, common femoral, or popliteal artery

Endovascular Therapy

Description:

angioplasty and/or stent to treat lesions in the superficial femoral or popliteal artery

Medical Management

Description:

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