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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01588067
First Posted: April 30, 2012
Last Update Posted: July 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Kaiser Permanente
  Purpose
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.

Condition
Peripheral Arterial Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial Disease.

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Change from baseline in Health Status at 6 months [ Time Frame: Baseline (pre procedure), 6 months ]
    Health Status will be measured at baseline and six months following the procedure


Enrollment: 271
Study Start Date: May 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population includes patients with PAD
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588067


Locations
United States, Colorado
VA Eastern Colorado Health Care System
Denver, Colorado, United States, 80220
Kaiser Permanente Colorado
Denver, Colorado, United States, 80231
Sponsors and Collaborators
Kaiser Permanente
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: David Magid, MD, MPH Kaiser Permanente
  More Information

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01588067     History of Changes
Other Study ID Numbers: CO-10-1488
First Submitted: April 4, 2012
First Posted: April 30, 2012
Last Update Posted: July 8, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases