Overview

This trial is active, not recruiting.

Conditions peripheral arterial disease, claudication
Sponsor University of Washington
Start date July 2011
End date September 2014
Trial size 1100 participants
Trial identifier NCT01378260, 40153-D, R01HS2002501

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
use of synthetic or endogenous (vein) or composite graft to treat lesions in the superficial femoral, common femoral, or popliteal artery
angioplasty and/or stent to treat lesions in the superficial femoral or popliteal artery
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

Primary Outcomes

Measure
The primary outcome is the change in score on the Walking Impairment Questionnaire (WIQ) from the baseline assessment to the 12-month assessment.
time frame: 12-Months Post-Index Date

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)
Principal investigator David R Flum, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by University of Washington.