Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

323 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Arterial Disease Claudication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgical Bypass

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

No interventions assigned to this group

Endovascular Therapy

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No