NCT01588067

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
271

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2012

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

July 8, 2015

Status Verified

July 1, 2015

Enrollment Period

3.3 years

First QC Date

April 4, 2012

Last Update Submit

July 6, 2015

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Health Status at 6 months

    Health Status will be measured at baseline and six months following the procedure

    Baseline (pre procedure), 6 months

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes patients with PAD

You may qualify if:

  • 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)

You may not qualify if:

  • dementia,
  • inability to consent,
  • pregnancy,
  • limited life expectancy (\< 6 months),
  • previous endovascular or surgical revascularization within the previous 12 months,
  • non English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Eastern Colorado Health Care System

Denver, Colorado, 80220, United States

Location

Kaiser Permanente Colorado

Denver, Colorado, 80231, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • David Magid, MD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2012

First Posted

April 30, 2012

Study Start

May 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

July 8, 2015

Record last verified: 2015-07

Locations

US(2)