Peripheral Arterial DiseaseNCT01378260
Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)
An observational study of Peripheral Arterial Disease and Claudication, run by University of Washington at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Claudication
- Type of treatment
- Injection or infusion
- How many people
- 323 participants
- Where
- 12 sitesUnited States
- Study dates
- Jul 2011to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients being seen by a physician with newly diagnosed or established claudication
Who may be able to join
- Diagnosis of claudication
- 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)
Who cannot join
- those with documented acute ischemia, rest pain or ulceration
- those with claudication determined to be of aortic or iliac origin
- those with claudication that is not caused by atherosclerotic disease
- those without access to a telephone or Internet and are unwilling to participate in surveys by mail at home (assess in patient screen)
- those who otherwise refuse to participate (assessed in patient screen)
- those who have a diagnosis of dementia confirmed in their medical record
- those who are not English speaking
- children and young adults up to and including age 20-years
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Lake Washington Vascular
Bellevue, Washington, 98004
PeaceHealth St. Joseph Medical Center
Bellingham, Washington, 98225
Providence Everett
Everett, Washington, 98201
St. Francis Hospital
Federal Way, Washington, 98003
Good Samaritan Hospital
Puyallup, Washington, 98372
Harborview Medical Center
Seattle, Washington, 98104
Northwest Hospital and Medical Center
Seattle, Washington, 98133
University of Washington
Seattle, Washington, 98195
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
St. Joseph Medical Center
Tacoma, Washington, 98405
Tacoma General Hospital
Tacoma, Washington, 98405
PeaceHealth Southwest Medical Center - Thoracic & Vascular Surgery
Vancouver, Washington, 98664
About this study
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.
- Conditions
- Peripheral Arterial Disease, Claudication
- Keywords
- Peripheral Arterial Disease, Claudication, Comparative Effectiveness Research, PAD Study, PAD, atherosclerosis, Intermittent claudication, leg pain
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the change in score on the Walking Impairment Questionnaire (WIQ) from the baseline assessment to the 12-month assessment.
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.
Measured: 12-Months Post-Index Date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Flum, University of Washington
- Investigators
- David R Flum, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378260
- Sponsor's protocol ID
- 40153
- Other IDs
- R01HS2002501
- Status last verified
- May 2017
- First submitted
- 13 Jun 2011
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)
- ClinicalTrials.gov ID
- NCT01378260
- Acronym / sponsor ID
- 40153
- Conditions
- Peripheral Arterial Disease, Claudication
- Keywords
- Peripheral Arterial Disease, Claudication, Comparative Effectiveness Research, PAD Study, PAD, atherosclerosis, Intermittent claudication, leg pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients being seen by a physician with newly diagnosed or established claudication
Key inclusion criteria (5 listed)
- Diagnosis of claudication
- Be undergoing one of three treatments for claudication:
Key exclusion criteria (8 listed)
- those with documented acute ischemia, rest pain or ulceration
- those with claudication determined to be of aortic or iliac origin
- those with claudication that is not caused by atherosclerotic disease
- those without access to a telephone or Internet and are unwilling to participate in surveys by mail at home (assess in patient screen)
- those who otherwise refuse to participate (assessed in patient screen)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
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Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
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Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
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Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Flum, MD principal investigator
University of Washington
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Claudication, run by University of Washington at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2017; AzTrials last refreshed its copy on 1 Nov 2026.