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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
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    Health Status will be measured at baseline and six months following the procedure


Estimated Enrollment: 450
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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588067

Contacts
Contact: Nicole Wagner, MPH 303-614-1223 Nicole.M.Wagner@kp.org

Locations
United States, Colorado
Kaiser Permanente Colorado Recruiting
Denver, Colorado, United States, 80231
Contact: Nikki Wagner, MPH     303-614-1223     Nicole.m.Wagner@kp.org    
Contact: Heather Nuanes, BS     303-614-1373     Heather.A.Nuanes@kp.org    
Principal Investigator: David J Magid, MD, MPH            
VA Eastern Colorado Health Care System Recruiting
Denver, Colorado, United States, 80220
Contact: Anne Lambert-Kerzner     303-370-7596     Anne.Lambert-Kerzner@va.gov    
Principal Investigator: Michael Ho, MD            
Sponsors and Collaborators
Kaiser Permanente
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: David Magid, MD, MPH Kaiser Permanente
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01588067     History of Changes
Other Study ID Numbers: CO-10-1488
Study First Received: April 4, 2012
Last Updated: May 9, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on May 23, 2013