OEIS Outcome Data Registry

OEIS (Outpatient Endovascular and Interventional Society) Outcome Data Registry

This registry is created under the sponsorship of the Outpatient Endovascular and Interventional Society (OEIS) to monitor the clinical course and treatment outcomes of patients undergoing office-based endovascular procedures.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease

• Study Type: Observational
• Enrollment (Anticipated): 600000

Contacts and Locations

• Study Contact: Name: Dhru Bhatt; Phone Number: 8885486347; Email: DBhatt@association-resources.com
• Study Contact Backup: Name: Elizabeth Ouriel; Phone Number: 2128786882; Email: eouriel@syntactx.com

Study Locations

• United States
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Recruiting
      • Outpatient Endovascular Interventional Society (OEIS)
      • Contact: Jeff Carr; Phone Number: 903-521-6004; Email: jeffcarr@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients meeting the registry diagnostic and procedure inclusion criteria and that are treated at participating facilities by participating clinicians.

Description

Inclusion Criteria:

• Patient is 18 years of age or older;
• Patient is identified as having undergone a percutaneous transluminal vascular intervention or attempted intervention, in an ambulatory (outpatient) facility, for the treatment of peripheral vascular disease within native arteries or bypass grafts, from the infrarenal aorta distally to the feet.

Exclusion Criteria:

• Patient treated for a non-eligible condition or procedure
• Diagnostic procedures without intervention or attempted interventions
• Serious mental illness that might preclude subject's ability to comply with follow up
• Life expectancy of less than 6 months

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiplatelet Therapy (ACC/AHA/PAD Coalition)	To collect the clinical variables of Patients undergoing endovascular procedures in an outpatient angiograPercentage of patients with PAD that have been prescribed an antiplatelet medication at the reported encounter.	30 days
Preventive Care and Screening: Tobacco Use	Screening and Cessation Intervention. Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user.	30 days
Lipid-Lowering Medications for Patients with PAD	The rate at which patients with documented peripheral artery disease have documentation of a currently prescribed antihyperlipidemic medication treatment. This may include one of the following: Statin, Bile acid sequestrants, Niacin, Ezetemibe, Fibrates, PCSK9 Inhibitors	30 days
Optimal vascular care	This measure is a composite score of appropriate vascular care measures for treatment of PAD. This measure is a composite result of 1: Antiplatelet Therapy; 2: Preventive Care and Screening: Tobacco Use; and 3: Lipid-Lowering Medications (Statin) for Patients with PAD	30 days
Preventive Care and Screening: Influenza Immunization.		30 days
Pneumonia Vaccination Status for Older Adults.		30 days
Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented.		30 days
Appropriate non-invasive arterial testing for patients with intermittent claudication who are undergoing a lower extremity peripheral vascular intervention.	Proportion of patients with non-invasive evaluations present/available prior to lower extremity peripheral vascular interventions in patients with intermittent claudication.	30 days
Appropriate non-invasive arterial testing for patients with critical limb ischemia who are undergoing a LE peripheral vascular intervention.	Proportion of patients with non-invasive evaluations present/available prior to LE peripheral vascular interventions in patients with critical limb ischemia.	30 days
Emergent transfer from an outpatient, ambulatory surgical center, or office setting.	Rate of emergent transfer from an outpatient, ASC, or office setting to an acute care facility as a result of an invasive peripheral vascular intervention.	30 days

Collaborators and Investigators

• Sponsor: Outpatient Endovascular and Interventional Society
• Collaborators: Syntactx

Publications and helpful links

General Publications

• Carey K, Burgess JF Jr, Young GJ. Hospital competition and financial performance: the effects of ambulatory surgery centers. Health Econ. 2011 May;20(5):571-81. doi: 10.1002/hec.1617.
• Murer CG. Significant changes for ASC payment systems. Rehab Manag. 2007 Nov;20(9):42, 44-5. No abstract available.
• Lapetina EM, Armstrong EM. Preventing errors in the outpatient setting: a tale of three states. Health Aff (Millwood). 2002 Jul-Aug;21(4):26-39. doi: 10.1377/hlthaff.21.4.26.
• Kutscher B. Outpatient care takes the inside track. Mod Healthc. 2012 Aug 6;42(32):24-6. No abstract available.
• Lin PH, Yang KH, Kollmeyer KR, Uceda PV, Ferrara CA, Feldtman RW, Caruso J, Mcquade K, Richmond JL, Kliner CE, Egan KE, Kim W, Saines M, Leichter R, Ahn SS. Treatment outcomes and lessons learned from 5134 cases of outpatient office-based endovascular procedures in a vascular surgical practice. Vascular. 2017 Apr;25(2):115-122. doi: 10.1177/1708538116657506. Epub 2016 Jul 9.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 2016-OEIS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No