Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01378260

Enrollment

323

Registered

2011-06-22

Start date

2011-07-31

Completion date

2015-08-31

Last updated

2017-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Claudication, Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease, Claudication, Comparative Effectiveness Research, PAD Study, PAD, atherosclerosis, Intermittent claudication, leg pain

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results