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Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial Disease (PAD)

This study is currently recruiting participants.
Verified May 2013 by Kaiser Permanente
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01588067
First received: April 4, 2012
Last updated: May 9, 2013
Last verified: May 2013
History of Changes

April 4, 2012
May 9, 2013
May 2011
September 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01588067 on ClinicalTrials.gov Archive Site
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Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial Disease
Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial Disease.

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

The study population includes patients with PAD
Peripheral Arterial Disease
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  • Medical
    Patients treated for PAD medically or with exercise therapy
  • Endovascular
    Patients with PAD treated with endovascular therapy
  • Surgery
    Patients with PAD treated with surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • presents with PAD,
  • > 18 years of age,
  • can complete a questionnaire, and
  • has either had a change in PAD lower extremity intervention or start of a new intervention (surgical, endovascular, or medical therapy (cilostazol or exercise regimen)

Exclusion Criteria:

  • dementia,
  • inability to consent,
  • pregnancy,
  • limited life expectancy (< 6 months),
  • previous endovascular or surgical revascularization within the previous 12 months,
  • non English speaking
Both
18 Years and older
No
Contact: Nicole Wagner, MPH 303-614-1223 Nicole.M.Wagner@kp.org
United States
 
NCT01588067
CO-10-1488
No
Kaiser Permanente
Kaiser Permanente
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: David Magid, MD, MPH Kaiser Permanente
Kaiser Permanente
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP