VascTrac Peripheral Arterial Disease (PAD) Study

NCT ID: NCT03048890

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2023-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

VascTrac is a mobile medical application that tracks users' physical activity levels in order to predict endovascular failure of patients with Peripheral Artery Disease.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

VascTrac uses open-source software from Apple's ResearchKit to passively track physical activity levels of users who sign up. The goal is to predict post-intervention endovascular failure before it occurs. Currently, physicians have no way of knowing when procedures such as angioplasties fail; with VascTrac, researchers hope to find downward trends in physical activity that will predict and indicate endovascular failure. All users are assigned numbers and their medical data is securely coded, decreasing the risk of promulgation of personal information.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Artery Disease Intermittent Claudication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with PAD

Patients with PAD will be in 1 cohort and will have their physical activity levels closely monitored by researchers and physicians.

Physical activity levels

Intervention Type BEHAVIORAL

Patients with severely low physical activity levels will be notified to consult their physician.

Patients without PAD

Patients without PAD will be allowed to contribute their data to the application, but they will not be as closely monitored.

Physical activity levels

Intervention Type BEHAVIORAL

Patients with severely low physical activity levels will be notified to consult their physician.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physical activity levels

Patients with severely low physical activity levels will be notified to consult their physician.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* adult, has iPhone 5s, can read English

Exclusion Criteria

* under 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

W.L.Gore & Associates

INDUSTRY

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role collaborator

Cook Group Incorporated

INDUSTRY

Sponsor Role collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Oliver Aalami

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Oliver O Aalami, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Oliver O Aalami, MD

Role: CONTACT

650-852-3451

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Oliver Aalami, MD

Role: primary

650-493-5000 ext. 63675

References

Explore related publications, articles, or registry entries linked to this study.

Cunningham MA, Swanson V, Pappas E, O'Carroll RE, Holdsworth RJ. Illness beliefs and walking behavior after revascularization for intermittent claudication: a qualitative study. J Cardiopulm Rehabil Prev. 2014 May-Jun;34(3):195-201. doi: 10.1097/HCR.0000000000000046.

Reference Type BACKGROUND
PMID: 24603143 (View on PubMed)

Carter T, O'Neill S, Johns N, Brady RR. Contemporary vascular smartphone medical applications. Ann Vasc Surg. 2013 Aug;27(6):804-9. doi: 10.1016/j.avsg.2012.10.013. Epub 2013 Mar 25.

Reference Type BACKGROUND
PMID: 23535521 (View on PubMed)

Coughlin PA, Kent PJ, Turton EP, Byrne P, Berridge DC, Scott DJ, Kester RC. A new device for the measurement of disease severity in patients with intermittent claudication. Eur J Vasc Endovasc Surg. 2001 Dec;22(6):516-22. doi: 10.1053/ejvs.2001.1528.

Reference Type BACKGROUND
PMID: 11735200 (View on PubMed)

Gernigon M, Le Faucheur A, Fradin D, Noury-Desvaux B, Landron C, Mahe G, Abraham P. Global positioning system use in the community to evaluate improvements in walking after revascularization: a prospective multicenter study with 6-month follow-up in patients with peripheral arterial disease. Medicine (Baltimore). 2015 May;94(18):e838. doi: 10.1097/MD.0000000000000838.

Reference Type BACKGROUND
PMID: 25950694 (View on PubMed)

Afaq A, Patel JH, Gardner AW, Hennebry TA. Predictors of change in walking distance in patients with peripheral arterial disease undergoing endovascular intervention. Clin Cardiol. 2009 Sep;32(9):E7-11. doi: 10.1002/clc.20553.

Reference Type BACKGROUND
PMID: 19645033 (View on PubMed)

Malgor RD, Alahdab F, Elraiyah TA, Rizvi AZ, Lane MA, Prokop LJ, Phung OJ, Farah W, Montori VM, Conte MS, Murad MH. A systematic review of treatment of intermittent claudication in the lower extremities. J Vasc Surg. 2015 Mar;61(3 Suppl):54S-73S. doi: 10.1016/j.jvs.2014.12.007. Epub 2015 Feb 23.

Reference Type BACKGROUND
PMID: 25721067 (View on PubMed)

Murphy TP, Hirsch AT, Ricotta JJ, Cutlip DE, Mohler E, Regensteiner JG, Comerota AJ, Cohen DJ; CLEVER Steering Committee. The Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) study: rationale and methods. J Vasc Surg. 2008 Jun;47(6):1356-63. doi: 10.1016/j.jvs.2007.12.048. Epub 2008 Apr 25.

Reference Type BACKGROUND
PMID: 18440181 (View on PubMed)

Murphy TP, Cutlip DE, Regensteiner JG, Mohler ER, Cohen DJ, Reynolds MR, Massaro JM, Lewis BA, Cerezo J, Oldenburg NC, Thum CC, Goldberg S, Jaff MR, Steffes MW, Comerota AJ, Ehrman J, Treat-Jacobson D, Walsh ME, Collins T, Badenhop DT, Bronas U, Hirsch AT; CLEVER Study Investigators. Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the claudication: exercise versus endoluminal revascularization (CLEVER) study. Circulation. 2012 Jan 3;125(1):130-9. doi: 10.1161/CIRCULATIONAHA.111.075770. Epub 2011 Nov 16.

Reference Type BACKGROUND
PMID: 22090168 (View on PubMed)

Murphy TP, Hirsch AT, Cutlip DE, Regensteiner JG, Comerota AJ, Mohler E, Cohen DJ, Massaro J; CLEVER Investigators. Claudication: exercise vs endoluminal revascularization (CLEVER) study update. J Vasc Surg. 2009 Oct;50(4):942-945.e2. doi: 10.1016/j.jvs.2009.04.076. Epub 2009 Aug 5.

Reference Type BACKGROUND
PMID: 19660897 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AAL0001ARG

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PAD Screening Study
NCT05584072 UNKNOWN
Distrupt Stiffness Trial
NCT07130526 RECRUITING NA