Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial Disease (PAD)
This study is designed to develop a clinical registry of Peripheral Arterial Disease (PAD) patients undergoing lower extremity revascularization to describe the population and assess comparative effectiveness of endovascular therapy versus surgery. In addition, this study will conduct a prospective cohort study of patients treated medically or undergoing lower extremity revascularization at the VA and Kaiser Colorado to compare changes in health status.
Peripheral Arterial Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial Disease.|
- Change from baseline in Health Status at 6 months [ Time Frame: Baseline (pre procedure), 6 months ] [ Designated as safety issue: No ]Health Status will be measured at baseline and six months following the procedure
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Patients treated for PAD medically or with exercise therapy
Patients with PAD treated with endovascular therapy
Patients with PAD treated with surgery
Using electronic medical records, a registry of patients undergoing lower extremity revascularization therapy will be identified. Chart reviews with be done by an expert panel.
The prospective cohort study will ask participants to complete health status surveys before they begin therapy for PAD and again 6 months later.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588067
|United States, Colorado|
|Kaiser Permanente Colorado|
|Denver, Colorado, United States, 80231|
|VA Eastern Colorado Health Care System|
|Denver, Colorado, United States, 80220|
|Principal Investigator:||David Magid, MD, MPH||Kaiser Permanente|