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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01588067
First received: April 4, 2012
Last updated: May 15, 2014
Last verified: May 2014
  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 ] [ 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588067

Locations
United States, Colorado
Kaiser Permanente Colorado
Denver, Colorado, United States, 80231
VA Eastern Colorado Health Care System
Denver, Colorado, United States, 80220
Sponsors and Collaborators
Kaiser Permanente
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 15, 2014
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 July 23, 2014