Effectiveness of Medical Therapy, Endovascular Therapy, a... | NCT01588067

Studies
Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial Disease

NCT01588067

Sponsor

Kaiser Permanente

Status

Completed

Last Update Posted

Jul 8, 2015Estimated

Enrollment

271Actual

Phase

Not provided

Conditions

Peripheral Arterial Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Apr 4, 2012

First Submission Date that Met QC Criteria

Apr 26, 2012

First Posted Date

Apr 30, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2015

Last Update Posted Date

Jul 8, 2015Estimated

Name	Class
Agency for Healthcare Research and Quality (AHRQ)	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

271Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population includes patients with PAD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Magid, MD, MPH	Kaiser Permanente	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Eastern Colorado Health Care System		Denver	Colorado	80220	United States
Kaiser Permanente Colorado

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided