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NCT01378260 · ClinicalTrials.gov registry record
Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)
A clinical trial, sponsored by University of Washington.
- Completed
- Registry status
- 323
- Enrollment target
NCT01378260: Completed study, sponsored by University of Washington.
NCT01378260 is a clinical trial that has completed, run by University of Washington. The registered enrollment target is 323 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01378260 has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- 323 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-08 |
What the finished NCT01378260 record still lists
NCT01378260 is an observational study that tracks outcomes without assigning an intervention. The registered 323 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01378260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01378260 about?
NCT01378260 is a clinical study titled "Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)". 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...
What is the current status of trial NCT01378260?
This trial is currently completed. The enrollment target is 323 participants. The study started on 2011-07. Estimated completion is 2015-08.
Who is sponsoring clinical trial NCT01378260?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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