Clinical trial NCT01378260: Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)
Official title: Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Claudication
Keywords: Peripheral Arterial Disease
Claudication
Comparative Effectiveness Research
PAD Study
PAD
atherosclerosis
Intermittent claudication
leg pain
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2011-06-22
Enrollment: 323
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients being seen by a physician with newly diagnosed or established claudication

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.


Eligibility criteria: 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

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.
timeFrame: 12-Months Post-Index Date
Secondary outcomes:
Other outcomes:
Locations:
city: Bellevue
country: United States
facility: Lake Washington Vascular
state: Washington
city: Bellingham
country: United States
facility: PeaceHealth St. Joseph Medical Center
state: Washington
city: Everett
country: United States
facility: Providence Everett
state: Washington
city: Federal Way
country: United States
facility: St. Francis Hospital
state: Washington
city: Puyallup
country: United States
facility: Good Samaritan Hospital
state: Washington
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Northwest Hospital and Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center
state: Washington
city: Tacoma
country: United States
facility: St. Joseph Medical Center
state: Washington
city: Tacoma
country: United States
facility: Tacoma General Hospital
state: Washington
city: Vancouver
country: United States
facility: PeaceHealth Southwest Medical Center - Thoracic & Vascular Surgery
state: Washington
Study officials:
affiliation: University of Washington
name: David R Flum, MD
role: PRINCIPAL_INVESTIGATOR
References: