Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
David Flum, University of Washington
ClinicalTrials.gov Identifier:
NCT01378260
First received: June 13, 2011
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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.


Condition
Peripheral Arterial Disease
Claudication

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1100
Study Start Date: July 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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 or popliteal artery
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


  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients being seen by a physician with newly diagnosed or established claudication

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01378260

Locations
United States, Washington
Lake Washington Vascular
Bellevue, Washington, United States, 98004
PeaceHealth St. Joseph Medical Center
Bellingham, Washington, United States, 98225
Providence Everett
Everett, Washington, United States, 98201
St. Francis Hospital
Federal Way, Washington, United States, 98003
Good Samaritan Hospital
Puyallup, Washington, United States, 98372
Harborview Medical Center
Seattle, Washington, United States, 98104
University of Washington
Seattle, Washington, United States, 98195
Northwest Hospital and Medical Center
Seattle, Washington, United States, 98133
Providence Sacred Heart Medical Center
Spokane, Washington, United States, 99204
St. Joseph Medical Center
Tacoma, Washington, United States, 98405
Tacoma General Hospital
Tacoma, Washington, United States, 98405
PeaceHealth Southwest Medical Center - Thoracic & Vascular Surgery
Vancouver, Washington, United States, 98664
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: David R Flum, MD University of Washington
  More Information

No publications provided

Responsible Party: David Flum, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01378260     History of Changes
Other Study ID Numbers: 40153-D, R01HS2002501
Study First Received: June 13, 2011
Last Updated: November 6, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Washington:
Peripheral Arterial Disease
Claudication
Comparative Effectiveness Research
PAD Study
PAD
atherosclerosis
Intermittent claudication
leg pain

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014